Plasma Aβ Test Wins Approval—Are p-Tau Tests Far Behind?
Regulators in the U.S. and Europe have certified a mass-spectrometry-based blood test for amyloid-β. Plasma phospho-tau markers are poised to come next.
NEWS
Getting Under Your Skin: Does Vitiligo Elevate Dementia Risk?
In a retrospective study, people with vitiligo had 12 times the risk of developing Alzheimer’s disease than did healthy controls. Why is that?
In Phase 2 Trial, Neflamapimod Aids Cognition in Lewy Body Dementia
After missing primary endpoints in Alzheimer’s trials, this p38 MAPKa inhibitor gained some traction in a test in people with DLB.
Learning Troubles Spied by Smartphone Track with Biomarkers
Remote assessments on a smartphone closely matched tests taken in the clinic. They also may detect slip-ups in learning—an earlier cognitive deficit that arises in preclinical AD.
Aducanumab Still Needs to Prove Itself, Researchers Say
While the FDA weighs aducanumab’s marketing license application, Alzheimer’s researchers agree that the agency’s own statistician correctly assessed the data as weak. Most prefer that one more trial be done.
TRC-PAD Funnel Finally Touches Down
After years of building an online registry, designing selection algorithms, and getting sites up and running, COVID-19 nearly derailed this trial-ready cohort once again. Now, the first participants have reached the final queue.
BAN2401 Forges AHEAD into Phase 3, Preclinical AD
The anti-Aβ biologic will be put to the test in two stages of preclinical Alzheimer’s, designated by amyloid load. The long-dormant “est” PET tracer, NAV4694, is on board to make sensitive measurements.
BANish Aβ? BAN2401 Antibody Makes Its Move in Phase 3 Program
At CTAD, a Phase 2 open-label extension of this anti- Aβ protofibril antibody posted data as expected, and new Phase 3 trials for people with early and preclinical Alzheimer’s were described.
Virtual Exhibit Hall
Alzforum encourages users to visit the Virtual Exhibit Hall, where companies showcase their newest initiatives, products, and services. We welcome F. Hoffmann-La Roche, joining our other exhibitors — Biogen, BioLegend, Abcam, BrainXell, and the Jackson Laboratory.
SPOTLIGHT
Aducanumab Still Needs to Prove Itself, Researchers Say
It’s safe to say we all wanted this to work out. So why did the independent committee advising the FDA unanimously recommend against approving aducanumab now? The biostatisticians, neurologists, and other experts on the panel were troubled by the negative data from the Phase 3 ENGAGE trial, and by discrepancies in the EMERGE and even PRIME trials. The committee wants more data. It turns out Alzheimer’s clinicians do, too. This is a long story, on a topic we care about deeply. Grab your favorite beverage, and settle in for perhaps a difficult read.
BAN2401 Moves AHEAD into Phase 3
An anti-Aβ antibody with a penchant for soluble protofibrils, BAN2401 is moving into a multi-pronged Phase 3 program. As featured at this year’s virtual CTAD meeting, the antibody continued to knock down amyloid in a Phase 2 open-label extension. A Phase 3 in people with early AD is nearing full enrollment, while a paired Phase 2 and Phase 3 study called AHEAD 3-45 is gearing up for people with preclinical AD. A trial-ready cohort of amyloid-positive, cognitively normal volunteers is starting to serve its purpose.
Can Antibodies Prevent Plaque Seeding?
Scientists believe that Alzheimer’s disease starts when a teeny spec of Aβ seeds the fibrillization of amyloid plaques. Can immunotherapy nip this in the bud? Of five Aβ antibodies tested, aducanumab passed muster—in mice, that is. Five daily injections of the antibody reduced the seeding potential six weeks later by almost 90 percent.
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