Therapy Type: Small Molecule (timeline)
Target Type: Unknown
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2)
Merck is developing MK-7622 as an add-on therapy to the cholinesterase inhibitor donepezil for the treatment of Alzheimer's disease. No studies have been published on this compound in the peer-reviewed literature or other publicly available documents. Merck has published previously on its preclinical research of allosteric muscarinic agonists, which would enhance the effect of acetylcholine neurotransmission and could be suitable as adjunct therapy to cholinesterase inhibitors; however, it is unknown whether MK-7622 grew out of that program (see news story, see Uslaner et al., 2013).
No information about Phase 1 clinical studies of MK-7622 is available in the public domain. In October 2013, Merck began a Phase 2 trial in the United States to evaluate the compound's tolerability and efficacy as a symptomatic adjunct to donepezil therapy in patients with probable AD as diagnosed by two conventional diagnostic criteria, the NINCDS-ADRDA and DSM-IV.
This multicenter, 830-patient trial will use two stages to compare three doses of this compound, given as once-daily capsules. Stage 1 will randomize participants to receive either placebo or 45 mg of MK-7622 for six months. Interim analysis of Stage 1 data will determine if the trial proceeds to Stage 2. Stage 2 will randomize a separate group of participants to receive either placebo or 5, 15, or 45 mg of MK-7622 for six months.
The primary outcome measures are change from baseline in the ADAS-Cog11 at three months, the number of patients who have an adverse event, and the number of patients who drop out of the trial; this trial does not employ biomarkers. It is set to run until 2020. For clinical trials with this compound, see clinicaltrials.gov.
Clinical Trial Timeline
- Phase 2
- Study completed / Planned end date
- Planned end date unavailable
- Study aborted
- Uslaner JM, Eddins D, Puri V, Cannon CE, Sutcliffe J, Chew CS, Pearson M, Vivian JA, Chang RK, Ray WJ, Kuduk SD, Wittmann M. The muscarinic M1 receptor positive allosteric modulator PQCA improves cognitive measures in rat, cynomolgus macaque, and rhesus macaque. Psychopharmacology (Berl). 2012 Jul 24; PubMed.
No Available Further Reading