The main purpose of this study was to assess the safety and efficacy of MK-1942 as adjunctive therapy in participants with mild to moderate Alzheimer's Disease (AD) dementia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12
The change from baseline in ADAS-Cog11 score is presented. ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa.
Time frame: Baseline and Week 12
Number of Participants Experiencing an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to ~ 14 Weeks
Number of Participants Discontinuing Study Medication Due to an Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to ~ 12 Weeks
Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12
The overall score in ADCS-CGIC is presented. ADCS-CGIC is a global scale assessing cognition and function based on structured interviews of both the participant and study partner. ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of the study. Improvement in the ADCS-CGIC overall score, with a score of 1, 2, or 3 indicates improvement. The ADCS-CGIC is a clinician-rated measure of global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); and global change at follow-up scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change.
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Banner Alzheimer's Institute ( Site 0017)
Phoenix, Arizona, United States
Neurology Center of North Orange County ( Site 0039)
Fullerton, California, United States
California Neuroscience Research, LLC ( Site 0058)
Sherman Oaks, California, United States
JEM Research Institute ( Site 0013)
Atlantis, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 0025)
Hallandale, Florida, United States
K2 Medical Research ( Site 0057)
Maitland, Florida, United States
Premier Clinical Research Institute ( Site 0038)
Miami, Florida, United States
Collier Neurologic Specialists ( Site 0045)
Naples, Florida, United States
Atlanta Center for Medical Research ( Site 0044)
Atlanta, Georgia, United States
iResearch Atlanta ( Site 0016)
Decatur, Georgia, United States
...and 64 more locations
Time frame: Week 12
Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12
The change from baseline in ADCS-ADL score is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living. The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity.
Time frame: Baseline and Week 12