TrialPath
← Back to searchRecruiting

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

NCT07033494 · Merck Sharp & Dohme LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it
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 design
Enrollment target: 340 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-07-16
Estimated completion: 2029-04-30
Last updated: 2026-04-17
Interventions
Biological: MK-2214Drug: Placebo
Primary outcomes
  • Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr) (Baseline, up to approximately 23 months)
  • Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 26 months)
  • Number of Participants Who Discontinue Study Intervention Due to an AE (Up to approximately 23 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (71)
Irvine Clinical Research ( Site 1041)Recruiting
Irvine, California, United States
Healthy Brain Clinic ( Site 1005)Recruiting
Long Beach, California, United States
Inglewood Clinical ( Site 1062)Recruiting
Los Angeles, California, United States
Anderson Clinical Research ( Site 1024)Recruiting
Redlands, California, United States
UCSF Memory and Aging Center ( Site 1031)Recruiting
San Francisco, California, United States
Syrentis Clinical Research ( Site 1001)Recruiting
Santa Ana, California, United States
Yale University, Alzheimer's Disease Research Unit ( Site 1059)Recruiting
New Haven, Connecticut, United States
JEM Research Institute ( Site 1046)Recruiting
Atlantis, Florida, United States
Neuropsychiatric Research Center of Southwest Florida ( Site 1003)Recruiting
Fort Myers, Florida, United States
Indago Research & Health Center, Inc ( Site 1044)Recruiting
Hialeah, Florida, United States
K2 Medical Research ( Site 1047)Recruiting
Maitland, Florida, United States
ClinCloud LLC ( Site 1039)Recruiting
Melbourne, Florida, United States
Aqualane Clinical Research ( Site 1035)Recruiting
Naples, Florida, United States
Suncoast Clinical Research ( Site 1007)Recruiting
New Port Richey, Florida, United States
Renstar Medical Research ( Site 1012)Recruiting
Ocala, Florida, United States
Charter Research - Orlando ( Site 1051)Recruiting
Orlando, Florida, United States
Axiom Brain Health ( Site 1029)Recruiting
Tampa, Florida, United States
K2 Medical Research ( Site 1020)Recruiting
Tampa, Florida, United States
Charter Research - Lady Lake ( Site 1019)Recruiting
The Villages, Florida, United States
Conquest Research LLC ( Site 1053)Recruiting
Winter Park, Florida, United States
CenExel iResearch, LLC ( Site 1015)Recruiting
Decatur, Georgia, United States
Alexian Brothers Medical Center-Neurosciences ( Site 1017)Recruiting
Elk Grove Village, Illinois, United States
Boston Center for Memory ( Site 1008)Recruiting
Newton, Massachusetts, United States
Clinical Research Professionals ( Site 1004)Recruiting
Chesterfield, Missouri, United States
The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064)Recruiting
Ridgewood, New Jersey, United States
The Cognitive and Research Center of NJ ( Site 1057)Recruiting
Springfield, New Jersey, United States
CenExel- AMRI ( Site 1018)Recruiting
Toms River, New Jersey, United States
Alzheimer Disease Research Center (ADRC) ( Site 1000)Recruiting
Albany, New York, United States
Mid Hudson Medical Research ( Site 1050)Recruiting
New Windsor, New York, United States
Basil Clinical ( Site 1065)Recruiting
Queens, New York, United States
Insight Clinical Trials ( Site 1011)Recruiting
Independence, Ohio, United States
Neuro-Behavioral Clinical Research ( Site 1028)Recruiting
North Canton, Ohio, United States
Flourish Research ( Site 1048)Recruiting
Plymouth Meeting, Pennsylvania, United States
Gadolin Research ( Site 1032)Recruiting
Beaumont, Texas, United States
Horizon Clinical Research Center - Houston ( Site 1026)Recruiting
Cypress, Texas, United States
Organizacion Medica de Investigacion ( Site 0401)Recruiting
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400)Recruiting
Caba, Argentina
Southern Neurology ( Site 0306)Recruiting
Kogarah, New South Wales, Australia
KARA Institute for Neurological Diseases ( Site 0302)Recruiting
Macquarie Park, New South Wales, Australia
Austin Health ( Site 0300)Recruiting
Ivanhoe, Victoria, Australia
HammondCare ( Site 0301)Recruiting
Malvern, Victoria, Australia
Cliniques universitaires Saint-Luc ( Site 3001)Recruiting
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven ( Site 3000)Recruiting
Leuven, Vlaams-Brabant, Belgium
AZ Groeninge Campus Kennedylaan ( Site 3002)Recruiting
Kortrijk, West-Vlaanderen, Belgium
National Center for Geriatrics and Gerontology ( Site 9002)Recruiting
Ōbu, Aichi-ken, Japan
Chibaken Saiseikai Narashino Hospital ( Site 9000)Recruiting
Narashino, Chiba, Japan
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016)Recruiting
Kawasaki, Kanagawa, Japan
Mie University Hospital ( Site 9011)Recruiting
Tsu, Mie-ken, Japan
Katayama Medical Clinic ( Site 9005)Recruiting
Kurashiki, Okayama-ken, Japan
National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004)Recruiting
Kanzaki-gun, Saga-ken, Japan
Tokyo Medical University Hospital ( Site 9003)Recruiting
Shinjuku, Tokyo, Japan
Inage Neurology and Memory Clinic ( Site 9001)Recruiting
Chiba, Japan
Kyushu University Hospital ( Site 9010)Recruiting
Fukuoka, Japan
Okayama City General Medical Center Okayama City Hospital ( Site 9008)Recruiting
Okayama, Japan
Brain Research Center Den Bosch B.V. ( Site 5001)Recruiting
's-Hertogenbosch, North Brabant, Netherlands
Brain Research Center. ( Site 5000)Recruiting
Amsterdam, North Holland, Netherlands
Brain Research Center Zwolle ( Site 5002)Recruiting
Zwolle, Overijssel, Netherlands
Hanyang University Hospital ( Site 0200)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 0202)Recruiting
Seoul, South Korea
Ewha Womans University Seoul Hospital ( Site 0201)Recruiting
Seoul, South Korea
Hospital Universitari Mutua Terrassa ( Site 6004)Recruiting
Terrassa, Barcelona, Spain
Fundació ACE ( Site 6003)Recruiting
Barcelona, Catalonia, Spain
Hospital del Mar ( Site 6001)Recruiting
Barcelona, Spain
Hospital Clinic i Provincial ( Site 6002)Recruiting
Barcelona, Spain
Scottish Brain Sciences Aberdeen ( Site 8001)Recruiting
Aberdeen, Aberdeen City, United Kingdom
Scottish Brain Sciences ( Site 8000)Recruiting
Edinburgh, Edinburgh, City of, United Kingdom
Moorgreen Hospital ( Site 8004)Recruiting
Southampton, Hampshire, United Kingdom
Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006)Recruiting
London, London, City of, United Kingdom
Warneford Hospital ( Site 8007)Recruiting
Oxford, Oxfordshire, United Kingdom
Remind UK ( Site 8003)Recruiting
Bath, Somerset, United Kingdom
Re:Cognition Health - Birmingham ( Site 8002)Recruiting
Birmingham, United Kingdom
A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) · TrialPath