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

NCT07033494 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 2214-004MK-2214-0042024-519190-19-00U1111-1314-8296jRCT2031250299
• Study Type: interventional
• Target: 340
• Locations: 9 countries
• Sites: 71

Brief Summary

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

Conditions

Early Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)

  Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported.

  Baseline, up to approximately 23 months

• Number of Participants Who Experience One or More Adverse Events (AEs)

  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. The number of participants who experience one or more AEs will be reported.

  Up to approximately 26 months

• Number of Participants Who Discontinue Study Intervention Due to an 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. The number of participants who discontinue study intervention due to an AE will be reported.

  Up to approximately 23 months

Secondary Outcomes (7)

• Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score

  Baseline, up to approximately 23 months

• Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV

  Baseline, up to approximately 23 months

• Change from Baseline in the Composite Tau PET SUVr

  Baseline, up to approximately 23 months

• Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI

  Baseline, up to approximately 23 months

• Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score

  Baseline, up to approximately 23 months

Study Arms (2)

MK-2214

EXPERIMENTAL

Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study.

Biological: MK-2214

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo via IV infusion q4w during the study.

Drug: Placebo

Interventions

Placebo DRUG

IV infusion

Placebo

MK-2214 BIOLOGICAL

IV infusion

MK-2214

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (71)

Irvine Clinical Research ( Site 1041)

Irvine, California, 92614, United States

RECRUITING

Healthy Brain Clinic ( Site 1005)

Long Beach, California, 90804, United States

RECRUITING

Inglewood Clinical ( Site 1062)

Los Angeles, California, 90056, United States

RECRUITING

Anderson Clinical Research ( Site 1024)

Redlands, California, 92374, United States

RECRUITING

UCSF Memory and Aging Center ( Site 1031)

San Francisco, California, 94158, United States

RECRUITING

Syrentis Clinical Research ( Site 1001)

Santa Ana, California, 92705, United States

RECRUITING

Yale University, Alzheimer's Disease Research Unit ( Site 1059)

New Haven, Connecticut, 06510, United States

RECRUITING

JEM Research Institute ( Site 1046)

Atlantis, Florida, 33462, United States

RECRUITING

Neuropsychiatric Research Center of Southwest Florida ( Site 1003)

Fort Myers, Florida, 33912, United States

RECRUITING

Indago Research & Health Center, Inc ( Site 1044)

Hialeah, Florida, 33012, United States

RECRUITING

K2 Medical Research ( Site 1047)

Maitland, Florida, 32750, United States

RECRUITING

ClinCloud LLC ( Site 1039)

Melbourne, Florida, 32940, United States

RECRUITING

Aqualane Clinical Research ( Site 1035)

Naples, Florida, 34105, United States

RECRUITING

Suncoast Clinical Research ( Site 1007)

New Port Richey, Florida, 34652, United States

RECRUITING

Renstar Medical Research ( Site 1012)

Ocala, Florida, 34471, United States

RECRUITING

Charter Research - Orlando ( Site 1051)

Orlando, Florida, 32803, United States

RECRUITING

Axiom Brain Health ( Site 1029)

Tampa, Florida, 33609, United States

RECRUITING

K2 Medical Research ( Site 1020)

Tampa, Florida, 33634, United States

RECRUITING

Charter Research - Lady Lake ( Site 1019)

The Villages, Florida, 32162, United States

RECRUITING

Conquest Research LLC ( Site 1053)

Winter Park, Florida, 32789, United States

RECRUITING

CenExel iResearch, LLC ( Site 1015)

Decatur, Georgia, 30030, United States

RECRUITING

Alexian Brothers Medical Center-Neurosciences ( Site 1017)

Elk Grove Village, Illinois, 60007, United States

RECRUITING

Boston Center for Memory ( Site 1008)

Newton, Massachusetts, 02459, United States

RECRUITING

Clinical Research Professionals ( Site 1004)

Chesterfield, Missouri, 63005, United States

RECRUITING

The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064)

Ridgewood, New Jersey, 07450, United States

RECRUITING

The Cognitive and Research Center of NJ ( Site 1057)

Springfield, New Jersey, 07081, United States

RECRUITING

CenExel- AMRI ( Site 1018)

Toms River, New Jersey, 08755, United States

RECRUITING

Alzheimer Disease Research Center (ADRC) ( Site 1000)

Albany, New York, 12208, United States

RECRUITING

Mid Hudson Medical Research ( Site 1050)

New Windsor, New York, 12553, United States

RECRUITING

Basil Clinical ( Site 1065)

Queens, New York, 11413, United States

RECRUITING

Insight Clinical Trials ( Site 1011)

Independence, Ohio, 44131, United States

RECRUITING

Neuro-Behavioral Clinical Research ( Site 1028)

North Canton, Ohio, 44720, United States

RECRUITING

Flourish Research ( Site 1048)

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Gadolin Research ( Site 1032)

Beaumont, Texas, 77702, United States

RECRUITING

Horizon Clinical Research Center - Houston ( Site 1026)

Cypress, Texas, 77429, United States

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

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

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

Brain Research Center Den Bosch B.V. ( Site 5001)

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands

RECRUITING

Brain Research Center. ( Site 5000)

Amsterdam, North Holland, 1081 GN, Netherlands

RECRUITING

Brain Research Center Zwolle ( Site 5002)

Zwolle, Overijssel, 8025 AZ, Netherlands

RECRUITING

Hanyang University Hospital ( Site 0200)

Seoul, 04763, South Korea

RECRUITING

Samsung Medical Center ( Site 0202)

Seoul, 06351, South Korea

RECRUITING

Ewha Womans University Seoul Hospital ( Site 0201)

Seoul, 07804, South Korea

RECRUITING

Hospital Universitari Mutua Terrassa ( Site 6004)

Terrassa, Barcelona, 08222, Spain

RECRUITING

Fundació ACE ( Site 6003)

Barcelona, Catalonia, 08028, Spain

RECRUITING

Hospital del Mar ( Site 6001)

Barcelona, 08003, Spain

RECRUITING

Hospital Clinic i Provincial ( Site 6002)

Barcelona, 08036, Spain

RECRUITING

Scottish Brain Sciences Aberdeen ( Site 8001)

Aberdeen, Aberdeen City, AB25 2XE, United Kingdom

RECRUITING

Scottish Brain Sciences ( Site 8000)

Edinburgh, Edinburgh, City of, EH12 5PJ, United Kingdom

RECRUITING

Moorgreen Hospital ( Site 8004)

Southampton, Hampshire, SO30 3JB, United Kingdom

RECRUITING

Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006)

London, London, City of, NW1 2PG, United Kingdom

RECRUITING

Warneford Hospital ( Site 8007)

Oxford, Oxfordshire, OX3 7JX, United Kingdom

RECRUITING

Remind UK ( Site 8003)

Bath, Somerset, BA1 3NG, United Kingdom

RECRUITING

Re:Cognition Health - Birmingham ( Site 8002)

Birmingham, B16 8LT, United Kingdom

RECRUITING

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

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

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

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (3); AR (2); ES (4); BE (3); NL (3); JP (10); US (35); GB (7); AU (4)