The coronavirus pandemic is upending not only life as we knew it, but Alzheimer’s clinical studies as well. In the United States, Europe, and Australia, most sites have put observational cohort studies on hold, and many have stopped dosing and in-person clinic visits for treatment and prevention trials. Details vary from site to site, with clinics in less-hit areas continuing to administer treatments and monitor safety for enrolled participants—for now. The situation may change as the pandemic progresses, with all trials eventually suspending in-person contact, researchers acknowledge.

  • COVID-19 has shut down dosing in clinical trials worldwide.
  • Nearly all observational studies are paused.
  • Researchers turn to telemedicine to keep participants engaged.

What then? Across the board, clinic leaders said they are staying in contact with their participants and carers through remote methods such as phone calls, video conferences, internet contacts, even postcards. Researchers can continue to collect some clinical and cognitive data through these means. Meanwhile, they are using the down time to analyze data and prepare manuscripts.

How badly will these stoppages affect the trials? If the disruption due to coronavirus proves short-lived, on the order of two months or so, most of the two dozen researchers Alzforum heard from for this story thought the consequences would be manageable. Trials allow for some skipped doses, and there are statistical methods of dealing with what’s called data “missingness” (yes, that’s a thing). Researchers spoke of the need to obtain protocol waivers, catch up on assessments afterward, and possibly extend studies.

If the crisis stretches on, however, the damage of missed interventions could reach deeper into datasets, muddying interpretation of results and possibly derailing shorter trials altogether. Researchers also worry that some of their elderly participants could die from coronavirus, or become discouraged by the upheaval and drop out of Alzheimer’s studies. Some said that with recruitment halted and new trials on hold, the field may lose steam.

“This is an unparalleled event, which will have a huge impact on research in the long term,” Philip Scheltens at VU University, Amsterdam, told Alzforum. Others agreed that progress will stall, and said data integrity could be compromised by the massive protocol deviations required. “There are more questions than answers right now,” William Klunk at the University of Pittsburgh wrote to Alzforum. Even so, researchers across the board said they will continue pushing forward with the current trials, no matter how bad the disruption becomes. “We can’t quit now,” David Knopman at the Mayo Clinic in Rochester, Minnesota, told Alzforum.

Where the Virus Rages, It Takes Trials Down With It
In general terms, for a clinical trial, the extent of the damage depends on where its sites are located. At some centers, researchers have halted recruitment and most in-person visits, but still allow enrolled participants to come into the clinic to receive infusions of study drug, or other interventions. At the moment, this is the case in Melbourne, Australia, in Amsterdam, and at the Cleveland Clinic Lou Ruvo Center for Brain Health in Ohio, for example. At other sites, interventions are on hold, but participants may still come in for safety checks, such as MRI scans for ARIA. This is the status at Washington University in St. Louis, the Oregon Health and Science University in Portland, and Rush University in Chicago, among others. In some of the hardest-hit areas at this point, such as New York City, Boston, and Barcelona, Spain, everything is shut down. “So far, participants and sponsors have been quite understanding and supportive of our decision,” Gad Marshall at Brigham and Women’s Hospital in Boston wrote to Alzforum.

Clinic personnel are often left with difficult decisions as they weigh the potential risks and benefits of missed treatments versus possible exposure to coronavirus. Doug Galasko at the University of California, San Diego, said the Alzheimer’s Disease Research Center there is evaluating each trial separately, and still allowing some in-person visits for interventions that are deemed critical. Clinicians screen patients for coronavirus symptoms, wear protective equipment, and maintain social distancing during the visit. “This describes the situation today, but it is fluid, and [orders] may become more restrictive,” Galasko wrote.

For large multicenter trials, variability from site to site poses a particular problem, introducing heterogeneity. For example, A4 study visits are completely shut down at many U.S. sites, but continue as normal in Japan. “We are working to figure out the best options for sites in order to prioritize participant safety and minimize the impact to overall data integrity,” Reisa Sperling at Brigham and Women’s Hospital wrote to Alzforum. “The situation continues to evolve rapidly.”

John Dwyer, who runs the Global Alzheimer’s Platform Foundation based in Washington, D.C., said his organization is working with its sites and drug sponsors to try to blunt the pandemic’s effect on trials while keeping everyone safe. “We’re figuring out how we can creatively and responsibly adjust study protocols to maintain the integrity of the studies and keep the momentum,” he told Alzforum. For example, some sponsors are looking into administering drugs via home visits. Other aspects of studies, such as cognitive tests, can be completed remotely.

Pharmaceutical companies are in the same boat, trying to balance participant and staff safety against the need to continue treatment. Rachelle Doody at Roche told Alzforum that both enrollment and dosing are continuing in the company’s trials of gantenerumab and semorinemab, as well as in API’s study of crenezumab in Colombia. “The COVID-19 situation is dynamic, and we are reviewing the status of our clinical trials globally on an ongoing basis,” Doody wrote to Alzforum.

On the other hand, Eli Lilly is halting enrollment and postponing new trials while continuing dosing in ongoing trials, and other pharmaceutical companies are shifting their overall priorities away from some current indications and toward COVID-19 (Mar 23 Endpoint News; March 26 Endpoint News). 

The disruption may be most devastating to short trials. Li-Huei Tsai at Massachusetts Institute of Technology, Cambridge, is running a six-month trial of visual and auditory stimulation meant to synchronize gamma waves in the brain. Participants administer the intervention themselves at home, but need to come into the clinic every three months for testing. “Now none of those can be carried out. We are trying to change the protocol to [testing] every six months. I hope we can salvage the trial,” Tsai wrote to Alzforum. For other ongoing trials that were planned to last only a few weeks, she has had to simply stop the studies.

Despite the challenges now, most researchers believe a majority of ongoing trials can be preserved, provided the stoppage remains relatively brief. Statisticians will have to work out how to account for protocol deviations and analyze discrepant data, noted Mary Sano at Mount Sinai School of Medicine in New York. Dwyer praised recent guidance from the Food and Drug Administration and the National Institutes of Health. Both agencies have expressed an openness to granting protocol waivers and extensions. “They realize these are extraordinary times, and they’re encouraging flexibility and thoughtfulness to maintain participant and team safety,” Dwyer said.

James Leverenz at the Cleveland Clinic in Ohio said this is true of other study sponsors, too. “Our sponsors, including the NIH, to date have been supportive and understand the impact on our research productivity,” he wrote to Alzforum.

Richard Hodes, who leads the National Institute on Aging, said the NIA wants to hear from researchers about what impact the pandemic is having on their studies, and what is needed to maintain the work. “We want to understand what it will take to sustain the infrastructure during this pause, and what it will take to gear back up. We’re committed to doing that,” Hodes told Alzforum (see Mar 27 blog post for additional resources).

Observational Cohorts Try to Weather the Storm
The picture is more uniform for observational studies. Because clinic visits are not critical for participants’ health, this type of human AD research has been halted nearly everywhere, with but a few exceptions. Ricardo Allegri at the FLENI Neurological Research Institute in Buenos Aires, Argentina, who leads the DIAN study there, said that for now, his group is continuing to follow up with current participants, though they delayed enrolling new families. In Australia, visits are currently ongoing for AIBL participants; however, Chris Rowe at the University of Melbourne noted that imaging has been postponed, and visits are likely to be suspended altogether soon. In Sweden, the BioFINDER2 study is still allowing participants younger than 70 to come to the clinic for visits; this is based on guidance from the government. “These recommendations can change at any time,” noted Oskar Hansson at Lund University.

Researchers elsewhere, including across the United States, the Netherlands, and in Spain reported a complete stoppage of in-person visits. On March 24, The New York Times reported that 5,400 of Spain’s current documented 40,000 cases are among health care workers.

Enrollment of new participants into AD studies has halted everywhere. “We will from next week stop all new recruitments to the BioFINDER2 study, but we have already recruited 1,100 new subjects in the last 2.5 years, so it is not a catastrophe for the study,” Hansson wrote to Alzforum.

Most researchers believe the harm to long-term observational studies can be overcome. “Observational studies have much less frequent visits [than trials] and this situation is less likely to influence them,” Marshall wrote to Alzforum. David Bennett at Rush University in Chicago leads several large cohort studies, such as the Religious Orders Study and Rush Memory and Aging Project. He said, “Our studies will continue, but it will be a bit of work to get everything running like a machine again.” Hansson noted that if the pandemic lasts until July, BioFINDER2 will have a backlog of 150 lumbar punctures, 150 MRI scans, and 250 PET scans. “We might reduce the MRI protocol so each participant can be scanned in 20 minutes instead of 60 to more easily catch up,” Hansson wrote to Alzforum.

Michael Weiner at the University of California San Francisco, who runs ADNI, said the disruptions would harm that study’s data and budget. Other aspects of Alzheimer’s cohort studies are threatened as well. Bennett noted that his staff has had to halt autopsies of deceased participants until more protective gear arrives, to guard against coronavirus transmission.

New Reality for Scientists, Clinicians, Patients
Beyond affecting research studies, the coronavirus pandemic has transformed the work lives of researchers and clinicians themselves. Forced to stay at home, scientists are using the time to analyze data and write up results. “The research community is very resilient,” noted José Luis Molinuevo at Barcelonaβeta Brain Research Center in Spain. “I’m running my research team with virtual meetings every week. They are working from home, analyzing data we’ve collected over the last years, and getting new ideas.” Researchers are conferring with colleagues by video, and recording talks for upcoming conferences such as AAT-AD/PD, which will be fully virtual. Many wonder if the move toward remote interactions heralds a permanent change. “The world will never be the same after this,” Scheltens said.

The situation is more dire for researchers with clinical expertise, particularly in hard-hit areas. Molinuevo noted that doctors in his group have been deployed to help treat coronavirus patients, and laboratories are lending materials to hospitals. In New York, even non-clinicians from research groups volunteer in hospitals, where they help screen employees for possible coronavirus symptoms, or remind janitors to wear masks and gloves. “There’s a lot of operational work that needs to be done. The rules are changing so fast. Every day there’s a new set of screening questions,” Sano told Alzforum.

Areas that are further behind in the epidemic try to learn from the experience of New York, Italy, and Spain. For example, in Ottawa, Canada, health care workers are gowning up even for routine patient care, as presymptomatic spread of this highly transmissible new virus is becoming clear. This means that clinician-researchers like Michael Schlossmacher of the Ottawa Hospital Research Institute oversee the work of their research groups from home some days of the week, and on other days they don protective gear to see patients.  Schlossmacher's outpatient neurology clinic over the course of the past two weeks shifted more than 90 percent of its scheduled visits to secure video assessment or, where appropriate, phone calls. So far, both patients and practitioners feel this works well under the curcumstances, Schlossmacher wrote to Alzforum.

In many regions, neurodegeneration clinicians have not yet been tapped to help with general care, but that is likely coming, researchers said. In Chicago, Bennett’s clinic has been converted into a pediatric coronavirus screening site, and the hospital is in “surge mode,” with emergency rooms transformed into triage spaces in anticipation of a coming deluge of patients. “Right now it’s eerily quiet, but we expect things to pick up in the next week or so,” Bennett noted.

At the same time as clinicians are in demand, some researchers fear losing other research personnel because of a lack of work for them. Henne Holstege at Vrije University in Amsterdam recently hired a new employee to visit centenarians in their homes but, with all visits shut down, may be unable to renew this contract. Allegri noted that because of travel restrictions, he has been unable to train a new neurologist hired to evaluate DIAN participants. In addition to personnel problems, research clinics themselves are under financial pressure due to lost revenue. “I hope the new federally approved emergency funding will address the plight of hospitals and clinical trial sites,” Dwyer said.

The changes are especially hard on patients, who are now housebound. Because most participants in Alzheimer’s trials are over 65 and many have other health conditions, they are at high risk for complications and death from coronavirus. Even if they survive, Molinuevo fears that the trauma of going through a pandemic and potentially losing loved ones could precipitate trial dropouts.

Holstege is particularly concerned for her centenarians. “I am afraid to lose our whole cohort. We wrote all centenarians in the study a personal postcard to encourage them to keep strong and stay safe.”

Sano echoed the importance of staying in touch with participants, finding out what support they need, and reassuring them about future plans. It is helpful when trial leaders convey clear information about what protocol changes to expect, Sano said. “That helps our [clinic] staff give complete information to participants. If we don’t know what’s happening, that’s a hard message to share with patients.”

Many researchers worry about the effects of prolonged isolation on older participants. Jeffrey Kaye at the Oregon Health & Science University in Portland, a pioneer in home-based technology monitoring, tracks participant health and activity with a weekly questionnaire. He said that since the outbreak began, participants are more likely to report that they are lonely or depressed. Holstege agrees this is a huge problem. “In the long run, the loneliness that this viral outbreak inflicts on all elderly may turn out to be deadly, too,” she wrote.

To combat this, and to continue to gather data where possible, nearly all programs have turned to telemedicine. Researchers check in with participants via phone, video, or the internet. For the most part, participants are happy for the contact, researchers report. “A lot of these people are in lockdown, so they don’t mind if you call and keep them on the phone for an hour,” Bennett said.

Some researchers believe telemedicine may be the wave of the future for Alzheimer’s research. “The reliance on virtual meetings and remote assessments may well carry over once the pandemic ends,” predicted John Morris at Washington University in St. Louis. Galasko suggested that there could be a positive effect from this crisis if it helps researchers refine methods for remote assessment. Allegri’s group is also using this time to accelerate work on online cognitive assessments.

Kaye noted that the Centers for Medicare & Medicaid Services currently do not reimburse for telemedicine contacts. Allegri wrote that lack of telemedicine reimbursement from health insurance is a problem in Argentina, too. Both hope this crisis may change that policy. “For our populations, this option for assessment and care makes sense on so many levels,” Kaye wrote to Alzforum. However, he does not think it will ever fully replace in-person contact. “Technology is wonderful and helps us keep going in many ways, but ultimately human touch is still fundamental for us all.”

Overall, researchers vowed to find ways to deal with the challenges the pandemic poses. “We cannot let COVID-19 defeat our mission to find a successful treatment for Alzheimer’s disease,” Sperling said. Steven Salloway at Butler Hospital in Providence, Rhode Island, said his clinic is already preparing for life after the pandemic. “Staff are working hard to get new studies ready to launch and to be prepared to resume normal activities. … We are looking forward to the time when we can again move full-steam ahead in the fight against AD,” he wrote.

Dear readers around the globe: what’s this pandemic doing to your cohort studies and trials? Write to, and we will add your experience as a comment to this report.—Madolyn Bowman Rogers


  1. For the Harvard Aging Brain Study, we had decided on March 12 to postpone all clinic and imaging visits, given that most of our participants are in the high-risk group for COVID-19 complications. Soon after, our institution required that all observational studies cease in-person visits. Fortunately, we have terrific HABS research investigators and staff who were well prepared to work remotely, so we are continuing data analyses and working on manuscripts, as well as keeping in touch with our HABS participants by phone over the next few weeks to make sure they are coping at home as well as possible.

    For our multicenter AD prevention trials, there is a lot of variability in the current situation across the sites. We are working to figure out the best options for sites in order to prioritize participant safety and trying to minimize impact to the overall study data integrity. We should know more by the end of this week, but the situation continues to evolve rapidly.  

    We cannot let COVID-19 defeat our mission to find a successful treatment for Alzheimer’s disease, but we must do everything possible to keep people safe in the short term. We will make it through this challenge as we have come through multiple other challenges in these prevention trials, working together to do our very best in these unprecedented times!

  2. Here in Portland, we are under a state-mandated stay-at-home order. Oregon Health & Science University has closed all non-emergency clinical activity, e.g., outpatient appointments, elective surgery. All employees are to work from home unless providing an essential function for the health care mission; COVID-19 related research is considered essential.

    We are "seeing" our aging and dementia patients by phone and online, and ramping up our telemedicine operations. We have been keen to grow telemedicine from our research efforts on teledementia care. As a point of clarification, the U.S. CMS policy for telehealth services reimbursement changed this month in response to COVID-19. To quote: "Effective for services starting March 6, 2020, and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for Medicare telehealth services furnished to patients in broader circumstances." I hope that provider direct-to-home telemedicine remains a covered service available to all in the U.S. Hopefully, the CMS reimbursement restrictions on direct-to-home telemedicine for Medicare patients will have been lifted not only for this pandemic, but will be permanent CMS policy. It is obvious that, for our populations, this option for assessment and care makes sense on so many levels. 

    On the research front, all laboratories are closed except for ethical, e.g., animal care, or safety needs. All direct contact with study participants, whether in clinic or home, is stopped (a large number of our clinical research studies are conducted at home with home assessments). All clinical trial visits that are not directly for patient safety have ceased.  

    A major part of our clinical research here at OHSU focuses on remote monitoring using sensors and devices in the home to continually assess function. This work continues, with our staff keenly attuned to managing research cohorts remotely. These cohorts respond online to us with a weekly health and activity questionnaire; they continue to do so. We have noted more endorsement of low mood and loneliness items on this questionnaire.  

    We had a participant who lives alone who tested positive for COVID-19 following flu-like symptoms. She is fortunately recovering well, self-quarantined at home; none of our staff had direct contact with her before she became symptomatic. We are in the process of examining the activity data of the many home-monitored research participants in our studies, anticipating that we will see clear trends (e.g., changes in steps per day, sleep times, time out of home, weight/BMI, etc.) relative to the epidemic.

    This epidemic reminded me of an earlier study, where we were able to identify symptomatic individuals in a retirement community where a norovirus outbreak occurred, based on home activity patterns such as room transitions that were passively acquired with sensors (Campbell et al., 2011).  

    On a personal level, my colleagues have been so supportive of each other, setting up virtual breakrooms, additional Slack channels, and e-meetings. I hope everyone is well in our larger research community, and that it will be sooner than we think when we will again be able to see each other in person and be back to our familiar routines. Technology helps us keep going in many ways, but ultimately human touch is still fundamental for us all!


    . Measuring changes in activity patterns during a norovirus epidemic at a retirement community. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:6793-6. PubMed.

  3. In Pittsburgh, we have stopped all in-person research studies, which is essentially all our AD studies. This will obviously slow down progress, but could also lead to complications related to grant project timelines unless the granting agencies allow adequate flexibility. They have already started to do this, and I’m sure they will be open to meet more needs as they are presented.

    We have not been asked to reassign any staff as of yet. That would, of course, be voluntary. So far, health systems in the Pittsburgh area have not been overwhelmed in that way, but we’re still riding the upslope and no one knows what we’ll see before this is over. 

    But, over it will be sometime in the months ahead, and then we’ll see how successfully we can reconstitute things in light of the serious economic issues we’ll be facing for some time. How will that affect the funding increases we’ve enjoyed over the past four to five years, for example? There will be other problems, too; e.g., will the elderly volunteers be willing to come to university medical centers that they saw on the news as being the epicenter of treatment for COVID-19 patients?

    There are more questions than answers right now.

  4. The COVID-19 pandemic has had a tremendous impact on human subjects research in which I am involved. Our overarching policy is that we need to minimize risk for study participants and research staff. We also are cognizant of resource utilization, e.g., keeping clinical research space open impacts hospital resources, as does ordering laboratory tests or imaging studies. Observational studies are on hold, with no in-person visits. Clinical trials are being dealt with individually, with difficult decisions about what constitutes a critical intervention and trial. For example, a trial involving repeated drug infusion visits has a higher priority than an interim visit for clinical assessment. Research neuroimaging is on hold. Laboratory testing needs to be checked and considered, and it is necessary to confirm whether labs are open and receiving shipments. So far our study personnel have not been reassigned or called in for other duties, and we are accommodating working from home as much as possible.

    If a participant visit for a trial is deemed high priority and is planned and cannot be postponed, our working rules are to ensure that the staff and resources for the visit are available, and to contact the subject and informant to discuss whether they have had any symptoms of COVID-19. We recheck upon arrival at the clinic, and maintain social distancing during the visit. We are trying to have study staff issued with masks and personal protective equipment for the visit if possible, but because of the short supply, masks are not always available. This describes the situation today, and it is fluid, changing, and may become more restrictive.

    From an organizational viewpoint, we are reaching out to all participants in our observational studies and trials to ask how they are. Obviously, almost all are elderly and at high risk. We have assembled a list of local and national resources for people with Alzheimer’s Disease and their caregivers that we have posted on our ADRC website and are distributing as a link to all participants for whom we have email addresses. And we are drafting policies for NIH-funded trials that we are involved in, and notifying the IRB of updates. 

    It is difficult to keep up with the frequent email updates I receive that contain information and policy that includes details relevant to research. For example, I receive emails from my university, the VA, San Diego County, the state of California, NIH, leaders of clinical trials or clinical research programs, and others, as well as keeping up with the news. And the wide adoption of Zoom allows for conferencing, but there can be a fine line between effective communication and having clutter from an overabundance of Zoom conference calls.

    Clinically, we have rolled out telemedicine visits using video, which works reasonably well. Something positive that might come out of this crisis is how to do remote or in-home assessments as effectively as possible in research studies, including clinical trials.

    It has been incredibly heartwarming to see my colleagues and coworkers stepping up to help craft solutions.

  5. This pandemic is an unparalleled event, which will have a huge impact on research in the long term. The Netherlands is now in almost complete lockdown. Schools, restaurants, shops are all closed, everything except supermarkets, etc. In the hospitals, including mine, we have downscaled all care to the most urgent only and of course COVID patients. We do our consultation now almost only by telephone or Skype, which works quite well, and is mostly done from home. I am writing this from home as well. Lots of Zoom meetings from home with fellow staff members, Ph.D. students, and recording talks for symposia and congresses like AD/PD. The world will never be the same after this.

    As for research, all observational studies have been put on hold in terms of physical visits of participants to the center. Also because MRI and PET facilities have been scaled down to the utmost minimum for emergency use only. As for clinical trials, all screenings have been put on hold. Patients already randomized are being seen only when necessary, to receive infusions or otherwise. Most other visits are being done by telephone. Clinical trial staff, even non-MD’s, are all potentially available if urgently needed, but not yet the case. ICU capacity in the Netherlands is still OK and our government is really reacting pro-actively to support hospitals and hospital staff to the max.

  6. Until this pandemic has ended, we won’t know its full effects. For example, if clinical research is suspended for weeks or even a few months, there may not be much harm to our current longitudinal studies. Longer suspensions will make it much more difficult to recover our operations. We also may be adopting new methods whether we wish to or not: The reliance on virtual meetings and remote assessments may well carry over once the pandemic ends.

    Our faculty who are engaged in research and who also are physicians are being asked to “redeploy” and provide clinical care in the hospital in areas of need, e.g., the emergency department.

    At Washington University, human subject research now must be performed remotely, if at all.  I have suspended all Knight ADRC clinical and other assessments for our participants until at least April 30, when we will reassess. The exception is when the principal investigator of a study determines that an individual participant’s risk in missing a visit is greater than the potential exposure to COVID-19 by having an in-person visit. Then the in-person visit can proceed with appropriate safeguards, e.g., providing the participant with information about their risk of COVID-19 exposure, pre-screening for possible symptoms of COVID-19, redoing the workflow to maximize social distancing, etc. 

    An example could be a participant in a clinical trial of an investigational anti-Alzheimer drug, where there are known side effects such as amyloid-related imaging abnormalities, or ARIA. That individual can be seen in person to assess for side effects and, if indicated, have a scheduled brain MRI to assess the possibility of ARIA.  However, our medical center’s policy now states: Please note that in-person participant visits are no longer permitted for the sole purpose of avoiding irreparable harm to the study’s goals.

  7. We have postponed observational study visits but are continuing study infusions for now. Participant attendance is good, but we have seen a mild increase in cancellations because some retirement communities are encouraging residents to stay home, plus general concern about increased risk of exposure. We try to limit the visit to the study participant and no more than one person, if needed, to assist them. The staff calls the night before to check on their health status and we take their temperature and go through a health screen when they arrive. Staff are required to wear masks in patient areas and we do our best to maintain social distancing.

    Non-essential staff are encouraged to work from home. Staff working on site are required to take their temperature twice per day. Staff members who are not feeling well are advised to stay home and contact employee health. So far, there have been no requests to assign staff to other health settings. 

    We are providing telemedicine visits with some clinic patients. Our IRB is carefully monitoring study modifications to ensure safety, privacy, and update informed consent. 

    The dedication and teamwork of our staff and study participants has created a caring community that is helping people make it through this unprecedented health crisis. Staff are working hard to get new studies ready to launch and to be prepared to resume normal activities. We are looking forward to the time when we can move full-steam ahead in the fight against AD. Once things settle down, we think there will be a resurgence of interest in AD prevention.

  8. I fear for our centenarians. Today we wrote all centenarians in our study a personal postcard to encourage them to keep strong and stay safe. Centenarians always like it when we visit them, and we won’t be able to do so any longer, for at least a couple of months as it now looks like. I am afraid to lose our whole cohort.

    I had just hired additional personnel to recruit and visit new centenarians. But whether her contract will be prolonged after the first month remains to be seen, because I do not have any work for her. We can no longer go around the country to visit centenarians. And even if we could, we cannot draw blood samples, because there is no one in the lab to process the samples. Although there is no complete lockdown in The Netherlands, we are asked to stay inside as much as possible.

    We will be finishing things that are lying around for us to do, mostly administrative  work, and some analyses as well. Since many things can be done from our homes, we are not completely out of work. However, for those of us with children, the home-schooling is making work very difficult, as we now have two daytime jobs instead of one. 

    For the centenarian study in the long run: We will have a gap in follow-up visits and new centenarian recruitments into the study. It is  highly unfortunate that we have to arrest ongoing experiments in the lab. We will  not be generating new data as anticipated, and all progress will be stalled. 

    We’ll have to see where all of this brings us. But, in all honesty, first priority is that all our colleagues are safe and healthy. And I dearly hope that the centenarians will survive all of this. I have seen one news item from China that a 103 year old woman survived a coronavirus infection, and today I saw a news item that a 95-year-old from Italy survived it. So there is hope. 

    We should not underestimate the effect on centenarians of not being able to receive any visitors, or not to being able to go outside the house for several months. In the long run, the loneliness that this virus outbreak inflicts on all elderly may turn out to be deadly as well. We’re all hoping for the best.

    Incidentally, reading this article on Alzforum was a consolation. We’re all in this together, we’re all suffering, we’re all afraid to lose what took us so many years to build. But we are also all prepared to fix things when this is over and continue where we left off. At the same time, it is heartwarming to see that researchers and companies are putting their heads together to fight off COVID-19. These collaborations might bring very good things for the years to come.

  9. Since the vast majority of our research participants are older, in their 70s on average, we are especially concerned about their response to a virulent virus like COVID-19. Moreover, we do not consider the observational studies or clinical trials we perform as critical for the participants’ care. For that reason, we shut down our in-house clinical research operation, including clinical trials, on March 12. We are doing some remote assessments, such as reviewing adverse events and medication changes by phone. For some protocols, there are cognitive and daily functioning assessments that can be done remotely.

    We stopped all infusions of study drugs. Some sponsors are considering doing home infusions. However, we decided against it because we did not want to expose our participants to healthcare workers who are going from home to home to perform infusions. So far, sponsors have been quite understanding and supportive of our decision. Participants have also been very understanding of the situation. I know that some sites continue to perform infusions for their participants. This variability depends on the site and site PI, the facility or hospital they are in, and the state. In our case, our hospital strongly recommended remote work for all research a week after we made that decision at our center, and Massachusetts recommended remote work for all non-essential jobs this week.

    Unfortunately, it is likely that the interruption and/or modification of study drug administration and clinical assessments will influence the integrity of the clinical trials. For some drugs that are infused on a monthly basis, missing two or three infusions is acceptable and may not have a significant effect. However, for drugs that require infusions every two weeks, this may be more problematic. Our observational studies have much less frequent visits and this situation is less likely to influence these studies.

    So far none of our research staff have been pulled to help with clinical care.

  10. For active participants in medication trials, receiving medication or placebo, visits and treatments are continuing. We are not enrolling new participants into these studies at this time.

    For observational studies (no intervention), we are holding on further assessments for the safety of our participants and research staff. We have reached out to each of our study participants scheduled for upcoming treatment or observational research visits and discussed with them the rationale for these changes and our commitment to their safety and future research inclusion.

    Obviously, this is significantly impacting our subject enrollment for both treatment trials and observational studies. This is the immediate effect. It will take some time to regain the momentum needed for productive enrollment and study progress.

    We are focusing our efforts on the “paperwork” inherent in clinical research, including regulatory work, data entry, and other study tasks. Investigators are also working on projects such as progress reports for studies, data analysis, and paper writing. Research staff are working from a home on a rotating schedule to reduce potential exposure to virus.

    Those of us with clinical responsibilities are preparing for patient needs, as expected over the coming weeks and months. Reassignment of study personnel has not occurred at this time. 

    The sponsors, including the NIH, to date have been supportive and understand the impact on our research productivity.

    While this pandemic will slow our research progress, we are grateful to our study participants and study partners for their commitment to the research and are doing all we can to reduce their risk for COVID-19. Of course, this holds true for our research staff as well.

  11. At Roche and Genentech, our No. 1 priority remains the safety of our patient communities, partners, and employees during this continuing pandemic. In these unprecedented times, we remain committed to people living with Alzheimer’s disease and we are working hard to ensure our critical work to develop potential new medicines continues.

    The COVID-19 situation is dynamic, and we are reviewing the status of our clinical trials globally on an ongoing basis. We have not made a collective decision to pause studies or study enrollment across our clinical trial programs at this time, and continue to assess at the study, country, and site level. Roche’s clinical studies investigating potential therapies for Alzheimer’s disease are currently ongoing, including the Phase 3 GRADUATE studies of gantenerumab, the Phase 2 TAURIEL and LAURIET studies of semorinemab, and the Alzheimer’s Prevention Initiative (API) study of crenezumab in people at risk for autosomal dominant Alzheimer's disease (ADAD).

    We are committed to upholding the validity and integrity of our clinical trials, while finding new ways to adapt to potential challenges, such as travel limitations that impact patient site visits. For example, we know some of our trial sites are exploring ways to conduct trial assessments and coordinate care remotely through the help of telemedicine. We also understand the significant burden on clinical trial sites during this time and are working closely with site teams around the world to support them and the trial participants and rapidly address local questions and concerns related to our trials, in line with recent FDA and EMA guidance.

    We will continue to support local clinical trial sites that may need to make decisions in the best interests of their patients, their institutions and their communities to ensure patient safety and mitigate risks.

  12. As you probably are well aware, Spain is now in a complete lockdown. This has affected research centers like ours, Barcelonaβeta Brain Research Center, and the way we work. All participants from our observational studies, like the ALFA+ study, EPAD, AMYPAD, etc., and trials, PENSA, AB1601, are not allowed, by law, to come in, hence from a safety perspective we are on good grounds.

    We are aware of the impact on our studies, so we are working hard adapting them with the necessary protocol amendments to ensure their viability and validity after the crisis. Our IT teams are working on existing data to clean it and make it accessible to our research team, who are working from home. The team is focusing on analysis and writing results, so right now we are safely running the Alzheimer prevention program from home with frequents team video conferences. At the same time, we are preparing a protocol for contacting our research participants while the lockdown is in place and a protocol for restarting visits safely after the lockdown.

    I am aware that after the crisis, there will be less but still a COVID-19 infection risk, so apart from trying to generate part of our visits virtually, we want to make sure we have all necessary safety measures in place. We remain very active to preserve the work we have done to keep up the fight against Alzheimer's and dementia! Stay safe.

  13. For Alzheimer's disease research, the biggest danger of the COVID-19 (CV) pandemic is not transmission to staff or delay of projects. Little attention has been paid to the possibility this infection might distort the course of AD in patients and "normal" volunteers being followed. Senior citizens are a high-risk group for both illnesses. Loss of taste and smell, which are intimately connected to the nasal bulb and cranial nerves, have been reported in CV; anosmia can also be a harbinger of Alzheimer's.

    CV can produce viremia, which includes the brain, and headaches are a frequent symptom. CV is said to be neurotropic and to target the CNS (Baig et al., 2020). Nobody knows yet what the late sequelae will be, including effects on cognition. Many CV infections are asymptomatic, so affixing blame to them for dementia occurring years from now will be difficult. It should not surprise us if in the future coronavirus is isolated from the brains of some AD patients. And who knows, perhaps it can act as an infectious trigger of AD? 


    . Evidence of the COVID-19 Virus Targeting the CNS: Tissue Distribution, Host-Virus Interaction, and Proposed Neurotropic Mechanisms. ACS Chem Neurosci. 2020 Mar 13; PubMed.

  14. The evolving COVID-19 pandemic has placed tremendous strain on medical health care systems worldwide as they focus on the ongoing extraordinary medical emergency. Taking this into consideration, UCB has taken measures to protect our patients, trial personnel, and colleagues around the world. UCB is closely following the situation and is currently suggesting these general measures for clinical studies. This is in the context of pressurized health systems and with our primary focus on the safety of our patients.

    • To not initiate any new studies.
    • To temporarily halt recruitment into our ongoing clinical studies. Any exceptions to this are communicated by the program teams to the respective investigators.
    • For all patients who have been recruited into any UCB study, we will continue to focus on the care, access to study medication, clinical evaluations and safety monitoring. Taking a pragmatic approach, UCB is reviewing site visit requirements for regions and sites most impacted by the pandemic.  Any adaptations made will be proactively communicated to participants.

    We believe these measures will help lessen the impact on local health care provision, reduce the risk of patients being unable to receive full and appropriate medical oversight, and avoid the inherent risk of study-driven hospital/site visits. We will continue to monitor the situation and update our guidance to investigators as needed.

    Specific measures were taken for our ongoing trial studying the safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP). The PSP population, due to their age and potential disability, may be at higher risk of severe disease course related to SARS-Cov2 infection. To follow the suggested social distancing by individual health care systems, we have asked to avoid visits in clinical study sites. This is implemented using the facility in the protocol to miss a dose to allow pausing of the study medication until the situation again is more favorable for the health care system and safe for the individuals. We will closely follow the situation, including local guidances and status/needs in the health care system overall, guiding our decision in the light of the safety for our study participants.

  15. The Alzheimer’s Association's first priority is the health and safety of study participants and study staff, especially vulnerable elders and people with dementia and their families. In this new and uncertain environment, that means reconfiguring research studies, postponing them, or even temporarily halting them. We have heard from a number of neurodegenerative disease researchers who are finding innovative ways to keep their research moving forward during this difficult time, including linking their data into the Global Alzheimer’s Association Interactive Network (GAAIN) data-sharing platform, doing remote monitoring of clinical trial participants, and working on manuscripts. The Alzheimer's Association will continue to support and advocate for Alzheimer's and all dementia research during this uncertain time.

    For studies that are conducted by and in collaboration with the association, we have also seen an impact due to the evolving COVID-19 pandemic. The Alzheimer's Association and the Wake Forest University Medical Center (which serves as the study's coordinating center) have paused the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER). We are closely monitoring the COVID-19 pandemic and are acting to ensure the safety of participants and staff, and to protect the scientific integrity of the study. 

    It is our highest priority to keep the entire U.S. POINTER “family,” researchers and participants alike, safe and healthy. We continue to connect by mail and telephone with individuals who are interested in the study, and will evaluate the situation on an ongoing basis to gauge when the study can safely resume. These engagements will be tracked and monitored as a part of the study interventions. 

    The Alzheimer's Association will continue the momentum, as we can in this environment, because our commitment to the Alzheimer's community and the broader mission of the Alzheimer's Association is unwavering.

  16. The German Center for Neurodegenerative Diseases (DZNE) is currently running at a minimal operation mode. Like other institutions, we are thinking about ways to support the battle against COVID-19 by allocating personnel to fill clinical or administrative gaps at university hospitals or providing lab resources for virus testing.

    So far, the rate of infection among older adults has remained relatively low in Germany. Although this may be a result of the widespread testing, maintaining this situation has highest priority also for us. This, of course, also means that we have paused the DZNE–Longitudinal Cognitive Impairment and Dementia Study (DELCODE) to protect our vulnerable research participants.

    However, as with many longitudinal cohorts, we have built a close relationship with our participants over the years, and we therefore want to minimize their feeling of being isolated in this difficult period. To keep in touch, we will use telephone- based interviews and self-administered digital tests to monitor cognition. Hopefully, our research participants will get through this crisis safely, and we will all be able to look back at this episode knowing we have tried to keep in touch. We also hope that we will have some data to understand the toll isolation has taken on our participants’ cognition and mood.

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Therapeutics Citations

  1. Gantenerumab
  2. Semorinemab
  3. Crenezumab

Other Citations


External Citations

  1. Mar 23 Endpoint News
  2. March 26 Endpoint News
  3. Food and Drug Administration
  4. National Institutes of Health
  5. blog post
  6. The New York Times
  7. AAT-AD/PD

Further Reading