Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria: Has mild to moderate AD dementia based on the national institute of neurological and communicative diseases and stroke/Alzheimer's Disease and related disorders association (NINCDS-ADRDA) criteria. Has mini-mental state examination (MMSE) score between 12-22 (inclusive) at screening. Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia at Screening and during the study. These medications must be at stable approved dose levels ≥3 months before the first dose of study intervention and the regimens must remain constant throughout the study to the extent that is clinically appropriate. 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. Exclusion Criteria: Has a known history of stroke or cerebrovascular disease that is clinically important in the investigator's opinion. Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia (with protocol-specified exceptions). Has a history of seizures or epilepsy within the 10 years preceding Screening. Has any other major CNS trauma, or infections that affect brain function. Has evidence of a clinically relevant or unstable psychiatric disorder, based on criteria from the diagnostic and statistical manual of mental disorders (fifth edition), including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remission is not exclusionary. Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or administration intervention. Has a history of malignancy occurring within the 5 years immediately before Screening, except for a participant who has been adequately treated for 1 or more of the following: basal cell or squamous cell skin cancer; in situ cervical cancer; localized prostate carcinoma; who has undergone potentially curative therapy with no evidence of recurrence for ≥3 years post-therapy, and who is deemed to be at low risk for recurrence. Has a risk factor for QTc prolongation. Has a history of alcoholism or drug dependency/abuse within the 5 years preceding screening. Has a known allergy or intolerance to the active or inert ingredients in MK-1942. Has received any anti-amyloid agents or antibodies, or any of the following medications: CNS-penetrant anticholinergics, neuroleptics, anticonvulsants, narcotics, glutamatergic agents, agents with possible psychotropic effects, and experimental acute respiratory syndrome coronavirus 2 (COVID-19) therapies. Has liver disease, including but not limited to chronic viral hepatitis, non viral hepatitis, cirrhosis, malignancies, autoimmune liver diseases. Has an abnormal thyroid-stimulating hormone (TSH) value if confirmed by abnormal T4 value. Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision. Participant may reside in such facilities provided continuous direct medical care is not required and a qualified study partner is available for coparticipation and the participant is physically able to attend all required study visits. Had major surgical procedure or donated or lost >1 unit of blood (approximately 500 mL) within the 4 weeks before screening.
Sites / Locations
- Banner Alzheimer's Institute ( Site 0017)
- Neurology Center of North Orange County ( Site 0039)
- California Neuroscience Research, LLC ( Site 0058)
- JEM Research Institute ( Site 0013)
- Velocity Clinical Research, Hallandale Beach ( Site 0025)
- K2 Medical Research ( Site 0057)
- Premier Clinical Research Institute ( Site 0038)
- Collier Neurologic Specialists ( Site 0045)
- Atlanta Center for Medical Research ( Site 0044)
- iResearch Atlanta ( Site 0016)
- Alexian Brothers Medical Center ( Site 0011)
- Tandem Clinical Research ( Site 0055)
- Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)
- Advanced Memory Research Institute of New Jersey ( Site 0027)
- Richmond Behavioral Associates ( Site 0008)
- AMC Research, LLC ( Site 0004)
- NeuroScience Research Center ( Site 0009)
- Summit Headlands ( Site 0018)
- Grayline Research Center ( Site 0003)
- The Memory Clinic ( Site 0054)
- Re:Cognition Health ( Site 0031)
- Northwest Clinical Research Center ( Site 0056)
- Clinica Privada Banfield ( Site 0205)
- Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)
- Instituto Kremer ( Site 0202)
- IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
- Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)
- KARA Institute for Neurological Diseases ( Site 1902)
- Austin Health-Medical & Cognitive Research Unit ( Site 1901)
- HammondCare ( Site 1903)
- OCT Research ULC ( Site 0113)
- Centricity Research - Halifax ( Site 0111)
- Ottawa Memory Clinic ( Site 0105)
- Sunnybrook Health Sciences Centre ( Site 0106)
- Toronto Western Hospital-Memory clinic ( Site 0102)
- Clinique de la Mémoire de l'Outaouais ( Site 0114)
- Instituto Neurológico de Colombia ( Site 0415)
- Grupo Neurociencias de Antioquia ( Site 0417)
- Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)
- Fundacion Valle del Lili- CIC ( Site 0418)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204
- Ospedale San Raffaele ( Site 1202)
- Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)
- Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)
- Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)
- Kagawa University Hospital ( Site 2308)
- Kishiro Mental Clinic ( Site 2310)
- Kawasaki Saiwai Clinic ( Site 2302)
- Nagomi Clinic ( Site 2305)
- Tokyo Metropolitan Geriatric Hospital ( Site 2301)
- Ishikawa Clinic ( Site 2306)
- Himuro Neurology Clinic ( Site 2304)
- Inha University Hospital ( Site 2104)
- Asan Medical Center-Department of Neurology ( Site 2101)
- Samsung Medical Center ( Site 2102)
- Ewha Womans University Seoul Hospital ( Site 2103)
- CGM Research Trust ( Site 2001)
- Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)
- HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)
- Hospital de la Santa Creu i Sant Pau ( Site 1603)
- Clinica Universidad de Navarra-Neurology ( Site 1602)
- Centro de Atención Especializada Oroitu ( Site 1610)
- Hospital Universitario Doctor Peset-Neurología ( Site 1601)
- Fundació ACE ( Site 1604)
- Hospital Clinico San Carlos ( Site 1608)
- Hospital Viamed Montecanal-Neurociencia ( Site 1606)
- Brain Health Scotland Life Sciences ( Site 1810)
- Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)
- Re:Cognition Health - London ( Site 1804)
- Kingshill Research Centre ( Site 1807)
- Re:Cognition Health - Birmingham ( Site 1801)
- Re:Cognition Health - Plymouth ( Site 1803)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
MK-1942 5 mg
MK-1942 15 mg
Placebo
Participants will receive a single 5 mg MK-1942 capsule twice daily (BID), taken orally for 12 weeks. A mock titration will be done to maintain the study blind despite no changes in dose.
Participants will receive a single 8 mg MK-1942 capsule twice daily (BID), taken orally for one week. Then the dose is titrated up to 15 mg MK-1942 capsule twice daily (BID), taken orally for up to 11 weeks.
Participants will receive a placebo capsule twice daily (BID), taken orally for 12 weeks. A mock titration will be done to maintain the study blind despite no changes in dose.