A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)
- Registration Number
- NCT06721156
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers want to learn if giving MK-1167 (the study medicine) along with acetylcholinesterase inhibitor (AChEI) therapy can improve symptoms of Alzheimer's disease dementia (AD dementia), such as memory and mental activity. AD dementia is the most common type of dementia. AChEI therapy is the standard treatment for AD dementia.
The goals of this study are to learn:
* If at least one dose level (amount) of MK-1167 works to improve a person's memory and thinking compared to a placebo
* About the safety of MK-1167 and if people tolerate it
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Has mild to moderate Alzheimer's Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer's Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease
- Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)
- Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia
- Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status
- Has a known history of stroke or cerebrovascular disease
- Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically
- Has structural brain disease
- Has a history of seizures or epilepsy
- Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)
- Has major medical illness or unstable medical condition
- Has a history of malignancy
- Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)
- Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MK-1167 3 mg MK-1167 Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks. MK-1167 1 mg MK-1167 Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks. Placebo Placebo Participants take placebo QD for up to approximately 24 weeks. MK-1167 0.3 mg MK-1167 Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24 Baseline and up to approximately 24 weeks The change from baseline in ADAS-Cog11 score at Week 24 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.
Number of Participants Who Experience One or More Adverse Events (AEs) Up to approximately 28 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Intervention Due to an AE Up to approximately 24 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24 Baseline and up to approximately 24 weeks The overall score in ADCS-CGIC at Week 24 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study.
Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24 Baseline and up to approximately 24 weeks The change from baseline in ADCS-ADL score at Week 24 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). 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.
Change From Baseline in the ADAS-Cog11 Total Score at Week 12 Baseline and up to approximately 12 weeks The change from baseline in ADAS-Cog11 score at Week 12 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.
ADCS-CGIC Overall Score at Week 12 Baseline and up to approximately 12 weeks The overall score in ADCS-CGIC at Week 12 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study.
Change From Baseline in the ADCS-ADL Total Score at Week 12 Baseline and up to approximately 12 weeks The change from baseline in ADCS-ADL score at Week 12 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). 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.
Related Research Topics
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Trial Locations
- Locations (53)
Banner Alzheimer's Institute ( Site 0110)
🇺🇸Phoenix, Arizona, United States
Irvine Clinical Research ( Site 0104)
🇺🇸Irvine, California, United States
Anderson Clinical Research ( Site 0164)
🇺🇸Redlands, California, United States
California Neuroscience Research ( Site 0118)
🇺🇸Sherman Oaks, California, United States
JEM Research Institute / Headlands Research Network ( Site 0108)
🇺🇸Atlantis, Florida, United States
Brain Matters Research-Neurology ( Site 0150)
🇺🇸Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida ( Site 0152)
🇺🇸Fort Myers, Florida, United States
Indago Research & Health Center, Inc ( Site 0128)
🇺🇸Hialeah, Florida, United States
K2 Medical Research THE VILLAGES ( Site 0166)
🇺🇸Lady Lake, Florida, United States
K2 Medical Research ( Site 0103)
🇺🇸Maitland, Florida, United States
Premier Clinical Research Institute ( Site 0114)
🇺🇸Miami, Florida, United States
Aqualane Clinical Research ( Site 0116)
🇺🇸Naples, Florida, United States
Headlands Research Orlando ( Site 0169)
🇺🇸Orlando, Florida, United States
Brain Matters Research ( Site 0151)
🇺🇸Stuart, Florida, United States
K2 Medical Research Tampa LLC ( Site 0165)
🇺🇸Tampa, Florida, United States
Columbus Memory Center ( Site 0197)
🇺🇸Columbus, Georgia, United States
CenExel iResearch, LLC ( Site 0134)
🇺🇸Savannah, Georgia, United States
Tandem Clinical Research ( Site 0101)
🇺🇸Marrero, Louisiana, United States
Pharmasite Research, Inc. ( Site 0167)
🇺🇸Baltimore, Maryland, United States
Quest Research Institute ( Site 0173)
🇺🇸Farmington Hills, Michigan, United States
Velocity Clinical Research, Syracuse ( Site 0125)
🇺🇸East Syracuse, New York, United States
Mid Hudson Medical Research ( Site 0191)
🇺🇸New Windsor, New York, United States
Flourish Research - Charlotte ( Site 0106)
🇺🇸Matthews, North Carolina, United States
Velocity Clinical Research - Raleigh ( Site 0123)
🇺🇸Raleigh, North Carolina, United States
Summit Research Network ( Site 0111)
🇺🇸Portland, Oregon, United States
Kerwin Medical Center ( Site 0159)
🇺🇸Dallas, Texas, United States
Grayline Research Center ( Site 0105)
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center ( Site 0102)
🇺🇸Bellevue, Washington, United States
Okanagan Clinical Trials ( Site 0001)
🇨🇦Kelowna, British Columbia, Canada
Ottawa Memory Clinic ( Site 0004)
🇨🇦Ottawa, Ontario, Canada
Toronto Memory Program ( Site 0006)
🇨🇦Toronto, Ontario, Canada
Ospedale San Raffaele. ( Site 0901)
🇮🇹Milano, Italy
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510)
🇯🇵Kawasaki, Kanagawa, Japan
Kawasaki Saiwai Clinic ( Site 1501)
🇯🇵Kawasaki, Kanagawa, Japan
Hatsuta Neurology Clinic ( Site 1507)
🇯🇵Hirakata, Osaka, Japan
Nagomi Clinic ( Site 1506)
🇯🇵Toyonaka, Osaka, Japan
Takesato Hospital ( Site 1522)
🇯🇵Kasukabe, Saitama, Japan
Iwaki Clinic ( Site 1518)
🇯🇵Anan, Tokushima, Japan
Enomoto Internal Medicine Clinic(Chofu) ( Site 1503)
🇯🇵Chofu, Tokyo, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515)
🇯🇵Itabashi, Tokyo, Japan
Nozomi Memory Clinic ( Site 1504)
🇯🇵Mitaka, Tokyo, Japan
Itsuki Hospital ( Site 1502)
🇯🇵Tokushima, Japan
Inha University Hospital ( Site 1601)
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital ( Site 1604)
🇰🇷Seoul, Korea, Republic of
Brain Research Center Den Bosch B.V. ( Site 1002)
🇳🇱Den Bosch, Noord-Brabant, Netherlands
Brain Research Center. ( Site 1001)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Brain Research Center Zwolle ( Site 1003)
🇳🇱Zwolle, Overijssel, Netherlands
Centro de Atención Especializada Oroitu ( Site 1211)
🇪🇸Algorta, Bizkaia, Spain
Hospital de la Santa Creu i Sant Pau ( Site 1204)
🇪🇸Barcelona, Cataluna, Spain
Hospital Universitari i Politecnic La Fe ( Site 1202)
🇪🇸València, Valencia, Spain
Fundació ACE ( Site 1206)
🇪🇸Barcelona, Spain
Hospital Universitari Vall D Hebron ( Site 1203)
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de la Macarena ( Site 1210)
🇪🇸Sevilla, Spain