Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)
NCT ID: NCT05602727
Last Updated: 2024-12-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
99 participants
INTERVENTIONAL
2022-12-02
2023-09-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MK-1942 5 mg
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.
MK-1942
MK-1942 oral capsule
MK-1942 15 mg
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.
MK-1942
MK-1942 oral capsule
Placebo
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.
Placebo
Placebo oral capsule
Interventions
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MK-1942
MK-1942 oral capsule
Placebo
Placebo oral capsule
Eligibility Criteria
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Inclusion 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 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.
55 Years
90 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Alexian Brothers Medical Center ( Site 0011)
Elk Grove Village, Illinois, United States
Tandem Clinical Research ( Site 0055)
Marrero, Louisiana, United States
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)
Princeton, New Jersey, United States
Advanced Memory Research Institute of New Jersey ( Site 0027)
Toms River, New Jersey, United States
Richmond Behavioral Associates ( Site 0008)
Staten Island, New York, United States
AMC Research, LLC ( Site 0004)
Matthews, North Carolina, United States
NeuroScience Research Center ( Site 0009)
Canton, Ohio, United States
Summit Headlands ( Site 0018)
Portland, Oregon, United States
Grayline Research Center ( Site 0003)
Wichita Falls, Texas, United States
The Memory Clinic ( Site 0054)
Bennington, Vermont, United States
Re:Cognition Health ( Site 0031)
Fairfax, Virginia, United States
Northwest Clinical Research Center ( Site 0056)
Bellevue, Washington, United States
Clinica Privada Banfield ( Site 0205)
Banfield, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Kremer ( Site 0202)
Córdoba, Córdoba Province, Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
Buenos Aires, , Argentina
Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
Buenos Aires, , Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)
Buenos Aires, , Argentina
KARA Institute for Neurological Diseases ( Site 1902)
Sydney, New South Wales, Australia
Austin Health-Medical & Cognitive Research Unit ( Site 1901)
Ivanhoe, Victoria, Australia
HammondCare ( Site 1903)
Malvern, Victoria, Australia
OCT Research ULC ( Site 0113)
Kelowna, British Columbia, Canada
Centricity Research - Halifax ( Site 0111)
Halifax, Nova Scotia, Canada
Ottawa Memory Clinic ( Site 0105)
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre ( Site 0106)
Toronto, Ontario, Canada
Toronto Western Hospital-Memory clinic ( Site 0102)
Toronto, Ontario, Canada
Clinique de la Mémoire de l'Outaouais ( Site 0114)
Gatineau, Quebec, Canada
Instituto Neurológico de Colombia ( Site 0415)
Medellín, Antioquia, Colombia
Grupo Neurociencias de Antioquia ( Site 0417)
Medellín, Antioquia, Colombia
Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)
Bogotá, Bogota D.C., Colombia
Fundacion Valle del Lili- CIC ( Site 0418)
Cali, Valle del Cauca Department, Colombia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204
Milan, Lombardy, Italy
Ospedale San Raffaele ( Site 1202)
Milan, Lombardy, Italy
Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)
Monza, Lombardy, Italy
Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)
Brescia, , Italy
Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)
Kobe, Hyōgo, Japan
Kagawa University Hospital ( Site 2308)
Kita-gun, Kagawa-ken, Japan
Kishiro Mental Clinic ( Site 2310)
Kawasaki, Kanagawa, Japan
Kawasaki Saiwai Clinic ( Site 2302)
Saiwaiku,Kawasaki, Kanagawa, Japan
Nagomi Clinic ( Site 2305)
Toyonaka, Osaka, Japan
Tokyo Metropolitan Geriatric Hospital ( Site 2301)
tabashi City, Tokyo, Japan
Ishikawa Clinic ( Site 2306)
Kyoto, , Japan
Himuro Neurology Clinic ( Site 2304)
Osaka, , Japan
CGM Research Trust ( Site 2001)
Christchurch, Canterbury, New Zealand
Inha University Hospital ( Site 2104)
Incheon, , South Korea
Asan Medical Center-Department of Neurology ( Site 2101)
Seoul, , South Korea
Samsung Medical Center ( Site 2102)
Seoul, , South Korea
Ewha Womans University Seoul Hospital ( Site 2103)
Seoul, , South Korea
Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)
Terrassa, Barcelona, Spain
Centro de Atención Especializada Oroitu ( Site 1610)
Getxo, Basque Country, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau ( Site 1603)
Barcelona, Catalonia, Spain
Clinica Universidad de Navarra-Neurology ( Site 1602)
Pamplona, Navarre, Spain
Hospital Universitario Doctor Peset-Neurología ( Site 1601)
Valencia, Valenciana, Comunitat, Spain
Fundació ACE ( Site 1604)
Barcelona, , Spain
Hospital Clinico San Carlos ( Site 1608)
Madrid, , Spain
Hospital Viamed Montecanal-Neurociencia ( Site 1606)
Zaragoza, , Spain
Brain Health Scotland Life Sciences ( Site 1810)
Edinburgh, Edinburgh, City of, United Kingdom
Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)
Glasgow, Glasgow City, United Kingdom
Re:Cognition Health - London ( Site 1804)
London, London, City of, United Kingdom
Kingshill Research Centre ( Site 1807)
Swindon, Wiltshire, United Kingdom
Re:Cognition Health - Birmingham ( Site 1801)
Birmingham, , United Kingdom
Re:Cognition Health - Plymouth ( Site 1803)
Plymouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-1942-008
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031220532
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-006336-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1942-008
Identifier Type: -
Identifier Source: org_study_id