Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)

NCT05602727 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: 1942-008MK-1942-008jRCT20312205322021-006336-94
• Study Type: interventional
• Target: 99
• Locations: 11 countries
• Sites: 74

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to ~ 12 Weeks

Secondary Outcomes (2)

• Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12

  Week 12

• Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12

  Baseline and Week 12

Study Arms (3)

MK-1942 5 mg

EXPERIMENTAL

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.

Drug: MK-1942

MK-1942 15 mg

EXPERIMENTAL

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.

Drug: MK-1942

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

MK-1942 DRUG

MK-1942 oral capsule

MK-1942 15 mg; MK-1942 5 mg

Placebo DRUG

Placebo oral capsule

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (74)

Banner Alzheimer's Institute ( Site 0017)

Phoenix, Arizona, 85006, United States

Location

Neurology Center of North Orange County ( Site 0039)

Fullerton, California, 92835, United States

Location

California Neuroscience Research, LLC ( Site 0058)

Sherman Oaks, California, 91403, United States

Location

JEM Research Institute ( Site 0013)

Atlantis, Florida, 33462, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0025)

Hallandale, Florida, 33009, United States

Location

K2 Medical Research ( Site 0057)

Maitland, Florida, 32751, United States

Location

Premier Clinical Research Institute ( Site 0038)

Miami, Florida, 33122, United States

Location

Collier Neurologic Specialists ( Site 0045)

Naples, Florida, 34105, United States

Location

Atlanta Center for Medical Research ( Site 0044)

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta ( Site 0016)

Decatur, Georgia, 30030, United States

Location

Alexian Brothers Medical Center ( Site 0011)

Elk Grove Village, Illinois, 60007, United States

Location

Tandem Clinical Research ( Site 0055)

Marrero, Louisiana, 70072, United States

Location

Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)

Princeton, New Jersey, 08540, United States

Location

Advanced Memory Research Institute of New Jersey ( Site 0027)

Toms River, New Jersey, 08755, United States

Location

Richmond Behavioral Associates ( Site 0008)

Staten Island, New York, 10314, United States

Location

AMC Research, LLC ( Site 0004)

Matthews, North Carolina, 28105, United States

Location

NeuroScience Research Center ( Site 0009)

Canton, Ohio, 44718, United States

Location

Summit Headlands ( Site 0018)

Portland, Oregon, 97210, United States

Location

Grayline Research Center ( Site 0003)

Wichita Falls, Texas, 76309, United States

Location

The Memory Clinic ( Site 0054)

Bennington, Vermont, 05201, United States

Location

Re:Cognition Health ( Site 0031)

Fairfax, Virginia, 22031, United States

Location

Northwest Clinical Research Center ( Site 0056)

Bellevue, Washington, 98007, United States

Location

Clinica Privada Banfield ( Site 0205)

Banfield, Buenos Aires, 1828, Argentina

Location

Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)

Buenos Aires, Buenos Aires F.D., 1181, Argentina

Location

Instituto Kremer ( Site 0202)

Córdoba, Córdoba Province, X5004AOA, Argentina

Location

IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)

Buenos Aires, 1012, Argentina

Location

Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)

Buenos Aires, C1427CCP, Argentina

Location

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)

Buenos Aires, C1428AQK, Argentina

Location

KARA Institute for Neurological Diseases ( Site 1902)

Sydney, New South Wales, 2113, Australia

Location

Austin Health-Medical & Cognitive Research Unit ( Site 1901)

Ivanhoe, Victoria, 3079, Australia

Location

HammondCare ( Site 1903)

Malvern, Victoria, 3144, Australia

Location

OCT Research ULC ( Site 0113)

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Centricity Research - Halifax ( Site 0111)

Halifax, Nova Scotia, B3S 1N2, Canada

Location

Ottawa Memory Clinic ( Site 0105)

Ottawa, Ontario, K1Z1G3, Canada

Location

Sunnybrook Health Sciences Centre ( Site 0106)

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Western Hospital-Memory clinic ( Site 0102)

Toronto, Ontario, M5T 2S8, Canada

Location

Clinique de la Mémoire de l'Outaouais ( Site 0114)

Gatineau, Quebec, J8T 8J1, Canada

Location

Instituto Neurológico de Colombia ( Site 0415)

Medellín, Antioquia, 050012, Colombia

Location

Grupo Neurociencias de Antioquia ( Site 0417)

Medellín, Antioquia, Colombia

Location

Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)

Bogotá, Bogota D.C., 111166, Colombia

Location

Fundacion Valle del Lili- CIC ( Site 0418)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204

Milan, Lombardy, 20122, Italy

Location

Ospedale San Raffaele ( Site 1202)

Milan, Lombardy, 20132, Italy

Location

Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)

Monza, Lombardy, 20900, Italy

Location

Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)

Brescia, 25125, Italy

Location

Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)

Kobe, Hyōgo, 657-0825, Japan

Location

Kagawa University Hospital ( Site 2308)

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Kishiro Mental Clinic ( Site 2310)

Kawasaki, Kanagawa, 214-0014, Japan

Location

Kawasaki Saiwai Clinic ( Site 2302)

Saiwaiku,Kawasaki, Kanagawa, 212-0016, Japan

Location

Nagomi Clinic ( Site 2305)

Toyonaka, Osaka, 5600004, Japan

Location

Tokyo Metropolitan Geriatric Hospital ( Site 2301)

tabashi City, Tokyo, 173-0015, Japan

Location

Ishikawa Clinic ( Site 2306)

Kyoto, 606-0851, Japan

Location

Himuro Neurology Clinic ( Site 2304)

Osaka, 5340021, Japan

Location

CGM Research Trust ( Site 2001)

Christchurch, Canterbury, 8011, New Zealand

Location

Inha University Hospital ( Site 2104)

Incheon, 22332, South Korea

Location

Asan Medical Center-Department of Neurology ( Site 2101)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 2102)

Seoul, 06351, South Korea

Location

Ewha Womans University Seoul Hospital ( Site 2103)

Seoul, 07804, South Korea

Location

Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)

Terrassa, Barcelona, 08222, Spain

Location

Centro de Atención Especializada Oroitu ( Site 1610)

Getxo, Basque Country, 48993, Spain

Location

HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau ( Site 1603)

Barcelona, Catalonia, 08041, Spain

Location

Clinica Universidad de Navarra-Neurology ( Site 1602)

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Doctor Peset-Neurología ( Site 1601)

Valencia, Valenciana, Comunitat, 46017, Spain

Location

Fundació ACE ( Site 1604)

Barcelona, 08034, Spain

Location

Hospital Clinico San Carlos ( Site 1608)

Madrid, 28040, Spain

Location

Hospital Viamed Montecanal-Neurociencia ( Site 1606)

Zaragoza, 50012, Spain

Location

Brain Health Scotland Life Sciences ( Site 1810)

Edinburgh, Edinburgh, City of, EH12 9DQ, United Kingdom

Location

Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)

Glasgow, Glasgow City, G51 4TF, United Kingdom

Location

Re:Cognition Health - London ( Site 1804)

London, London, City of, W1G 9JF, United Kingdom

Location

Kingshill Research Centre ( Site 1807)

Swindon, Wiltshire, SN3 6BW, United Kingdom

Location

Re:Cognition Health - Birmingham ( Site 1801)

Birmingham, B16 8LT, United Kingdom

Location

Re:Cognition Health - Plymouth ( Site 1803)

Plymouth, PL6 8BT, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: December 2, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: December 10, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1); JP (8); AU (3); CO (4); IT (5); US (22); AR (6); ES (9); GB (6); CA (6); KR (4)