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A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

NCT ID: NCT07033494
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
Conditions: Early Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease

Enrollment: 340 participants (Estimated).

What is being studied

Biological: MK-2214
Drug: Placebo

Who may be eligible

Ages: 50 Years to 85 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) * Has a designated study partner who can fulfill the requirements of this study * If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a known history of stroke or cerebrovascular disease * Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically * Has structural brain disease * Has a history of seizures or epilepsy within 5 years before screening * Has any other major central nervous system trauma, or infections that affect brain function * Has major medical illness or unstable medical condition within 3 months before screening * Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality * Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study * Has a bleeding disorder that is not under adequate control * Has a history of malignancy occurring within 5 years of screening * Has a risk factor for corrected QT interval (QTc) prolongation * Has liver disease * Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan * Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision

Study locations

80 study locations are listed.

Recruiting site status is explicitly provided for 80 locations; 80 are listed as Recruiting.

Countries: Argentina, Australia, Belgium, Canada, Japan, Netherlands, Singapore, South Korea, Spain, United Kingdom, United States

Buenos Aires F.D., Argentina: 2
New South Wales, Australia: 2
Victoria, Australia: 2
Bruxelles-Capitale, Region de, Belgium: 1
Vlaams-Brabant, Belgium: 1
West-Vlaanderen, Belgium: 1
Ontario, Canada: 3
Quebec, Canada: 1
Aichi-ken, Japan: 1
Chiba, Japan: 1
Kanagawa, Japan: 1
Mie-ken, Japan: 1
Okayama-ken, Japan: 1
Osaka, Japan: 1
Saga-ken, Japan: 1
Tokyo, Japan: 1
North Brabant, Netherlands: 1
North Holland, Netherlands: 1
Overijssel, Netherlands: 1
Central Singapore, Singapore: 2
Barcelona, Spain: 1
Catalonia, Spain: 1
Aberdeen City, United Kingdom: 1
Edinburgh, City of, United Kingdom: 1
Hampshire, United Kingdom: 1
London, City of, United Kingdom: 1
Oxfordshire, United Kingdom: 1
Somerset, United Kingdom: 1
California, United States: 6
Connecticut, United States: 1

Sample of listed locations

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404) — Ciudad de Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina — Recruiting
Organizacion Medica de Investigacion ( Site 0401) — Ciudad de Buenos Aires, Buenos Aires F.D., C1015ABO, Argentina — Recruiting
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400) — Caba, C1428AQK, Argentina — Recruiting
Southern Neurology ( Site 0306) — Kogarah, New South Wales, 2217, Australia — Recruiting
KARA Institute for Neurological Diseases ( Site 0302) — Macquarie Park, New South Wales, 2113, Australia — Recruiting
Austin Health ( Site 0300) — Ivanhoe, Victoria, 3079, Australia — Recruiting
HammondCare ( Site 0301) — Malvern, Victoria, 3144, Australia — Recruiting
Cliniques universitaires Saint-Luc ( Site 3001) — Brussels, Bruxelles-Capitale, Region de, 1200, Belgium — Recruiting
UZ Leuven ( Site 3000) — Leuven, Vlaams-Brabant, 3000, Belgium — Recruiting
AZ Groeninge Campus Kennedylaan ( Site 3002) — Kortrijk, West-Vlaanderen, 8500, Belgium — Recruiting
Ottawa Memory Clinic ( Site 2001) — Ottawa, Ontario, K1Z 1G3, Canada — Recruiting
Sunnybrook Research Institute ( Site 2003) — Toronto, Ontario, M4N 3M5, Canada — Recruiting
Toronto Western Hospital ( Site 2004) — Toronto, Ontario, M5T 2S8, Canada — Recruiting
Clinique Mémoire de Montreal ( Site 2000) — Montreal, Quebec, H3G 1H9, Canada — Recruiting
National Center for Geriatrics and Gerontology ( Site 9002) — Ōbu, Aichi-ken, 474-8511, Japan — Recruiting
Chibaken Saiseikai Narashino Hospital ( Site 9000) — Narashino, Chiba, 275-8580, Japan — Recruiting
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016) — Kawasaki, Kanagawa, 210-0852, Japan — Recruiting
Mie University Hospital ( Site 9011) — Tsu, Mie-ken, 514-8507, Japan — Recruiting
Katayama Medical Clinic ( Site 9005) — Kurashiki, Okayama-ken, 710-0813, Japan — Recruiting
Hatsuta Neurology Clinic ( Site 9017) — Hirakata, Osaka, 573-1121, Japan — Recruiting
National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004) — Kanzaki-gun, Saga-ken, 8420192, Japan — Recruiting
Tokyo Medical University Hospital ( Site 9003) — Shinjuku, Tokyo, 160-0023, Japan — Recruiting
Inage Neurology and Memory Clinic ( Site 9001) — Chiba, 263-0043, Japan — Recruiting
Kyushu University Hospital ( Site 9010) — Fukuoka, 812-8582, Japan — Recruiting
Okayama City General Medical Center Okayama City Hospital ( Site 9008) — Okayama, 700-8557, Japan — Recruiting

Study details

Start date: July 16, 2025
Primary completion date: April 30, 2029
Completion date: April 30, 2030
First posted: June 24, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07033494
Registry last updated: October 8, 2026
QualifiedStudies registry data refreshed: October 12, 2026
QualifiedStudies record fetched: October 12, 2026

View NCT07033494 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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