Randomized, controlled, proof‐of‐concept trial of MK‐7622 in Alzheimer's disease
Key result
MK-7622 did not improve cognition at 12 weeks compared to placebo in mild-to-moderate Alzheimer's disease (mean difference 0.18; 95% CI -1.0 to 1.3), and the trial was stopped for futility.
Why the study?
Does MK-7622 improve cognition and function in individuals with mild-to-moderate Alzheimer's disease on acetylcholinesterase inhibitors?
Population
240 participants with mild-to-moderate Alzheimer's disease, being treated with an acetylcholinesterase…
Comparison
MK-7622 45 mg for 24 weeks vs Placebo for 24 weeks
Design
RCT, 1:1, double-blind
Follow-up
24 weeks
Authors
Discussion
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Implication
No cognitive benefit from MK-7622 added to AChEI in mild-to-moderate AD; confirms futility and closes this development path.
Study Design
Type
RCT (n=240)
Blinding
Double-blind
Randomization
1:1
Structured PICO
Does MK-7622 improve cognition and function in individuals with mild-to-moderate Alzheimer's disease on acetylcholinesterase inhibitors?
P
Population
240 participants with mild-to-moderate Alzheimer's disease on acetylcholinesterase inhibitor therapy, followed for 24 weeks.
I
Intervention
MK-7622 45 mg for 24 weeks
C
Comparator
Placebo for 24 weeks
O
Outcome
Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) at 12 weeks and Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory at 24 weekspatient reported
Main Result
Mean Difference: 0.18 (95% CI -1–1.3)
MK-7622 as adjunctive therapy does not improve cognition or function in mild-to-moderate Alzheimer's disease and is associated with more adverse events.
Cite This Study
Voss et al. (2018) conducted an RCT in Alzheimer's disease (n=240). MK-7622 vs. Placebo was evaluated on Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 11) at 12 weeks (MD 0.18, 95% CI -1.0 to 1.3). MK-7622 did not improve cognition at 12 weeks compared to placebo in mild-to-moderate Alzheimer's disease (mean difference 0.18; 95% CI -1.0 to 1.3), and the trial was stopped for futility.