Recruiting

Phase 2

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07033494

Conditions

Early Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

MK-2214

Placebo

Study Details

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

Study ID

NCT07033494

Start date

Jul 16, 2025

Status verified date

Aug, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MK-2214

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

placebo comparator: Placebo

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

Interventions

MK-2214

IV infusion

Placebo

IV infusion

Primary outcome measure

Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr) [ Time Frame: Baseline, up to approximately 23 months ]
Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 26 months ]
Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 23 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Irvine Clinical Research ( Site 1041)

Recruiting

Irvine, California, United States, 92614

Contacts

Study Coordinator

949-753-1663

Healthy Brain Clinic ( Site 1005)

Recruiting

Long Beach, California, United States, 90804

Contacts

Study Coordinator

562-606-5999

Inglewood Clinical ( Site 1062)

Recruiting

Los Angeles, California, United States, 90056

Contacts

Study Coordinator

949-265-1612

Anderson Clinical Research ( Site 1024)

Recruiting

Redlands, California, United States, 92374

Contacts

Study Coordinator

909-792-9007

UCSF Memory and Aging Center ( Site 1031)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

415-353-3585

Syrentis Clinical Research ( Site 1001)

Recruiting

Santa Ana, California, United States, 92705

Contacts

Study Coordinator

714-542-3008

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

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-764-8100

JEM Research Institute ( Site 1046)

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Study Coordinator

561-968-2933

Neuropsychiatric Research Center of Southwest Florida ( Site 1003)

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Study Coordinator

239-939-7777

K2 Medical Research ( Site 1047)

Recruiting

Maitland, Florida, United States, 32750

Contacts

Study Coordinator

407-500-5252

ClinCloud LLC ( Site 1039)

Recruiting

Melbourne, Florida, United States, 32940

Contacts

Study Coordinator

407-680-0534

Indago Research and Health Center Inc ( Site 1044)

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Study Coordinator

305-825-6588

Aqualane Clinical Research ( Site 1035)

Recruiting

Naples, Florida, United States, 34105

Contacts

Study Coordinator

239-529-6780

Suncoast Clinical Research ( Site 1007)

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

Study Coordinator

727-849-4131

Renstar Medical Research ( Site 1012)

Recruiting

Ocala, Florida, United States, 34471

Contacts

Study Coordinator

352-629-5800

Charter Research - Orlando ( Site 1051)

Recruiting

Orlando, Florida, United States, 32803

Contacts

Study Coordinator

407-337-3000

Axiom Brain Health ( Site 1029)

Recruiting

Tampa, Florida, United States, 33609

Contacts

Study Coordinator

813-353-9613

K2 Medical Research ( Site 1020)

Recruiting

Tampa, Florida, United States, 33634

Contacts

Study Coordinator

813-800-5252

Charter Research - Lady Lake ( Site 1019)

Recruiting

The Villages, Florida, United States, 32162

Contacts

Study Coordinator

352-775-1000

Conquest Research LLC ( Site 1053)

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Study Coordinator

407-916-0060

CenExel iResearch, LLC ( Site 1015)

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Study Coordinator

404-537-1281

Alexian Brothers Medical Center-Neurosciences ( Site 1017)

Recruiting

Elk Grove Village, Illinois, United States, 60007

Contacts

Study Coordinator

847-593-8553

Boston Center for Memory ( Site 1008)

Recruiting

Newton, Massachusetts, United States, 02459

Contacts

Study Coordinator

617-699-6927

Clinical Research Professionals ( Site 1004)

Recruiting

Chesterfield, Missouri, United States, 63005

Contacts

Study Coordinator

636-220-1200

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

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Study Coordinator

201-850-4622

The Cognitive and Research Center of NJ ( Site 1057)

Recruiting

Springfield, New Jersey, United States, 07081

Contacts

Study Coordinator

973-850-4622

CenExel- AMRI ( Site 1018)

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Study Coordinator

732-341-9500

Alzheimer Disease Research Center (ADRC) ( Site 1000)

Recruiting

Albany, New York, United States, 12208

Contacts

Study Coordinator

518-426-0575

Mid Hudson Medical Research ( Site 1050)

Recruiting

New Windsor, New York, United States, 12553

Contacts

Study Coordinator

845-674-9398

Basil Clinical ( Site 1065)

Recruiting

Queens, New York, United States, 11413

Contacts

Study Coordinator

917-672-3275

AMC Research, LLC ( Site 1006)

Recruiting

Matthews, North Carolina, United States, 28105

Contacts

Study Coordinator

704-364-4000

Insight Clinical Trials ( Site 1011)

Recruiting

Independence, Ohio, United States, 44131

Contacts

Study Coordinator

216-245-6556

Neuro-Behavioral Clinical Research ( Site 1028)

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Study Coordinator

330-493-1118

Flourish Research ( Site 1048)

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Contacts

Study Coordinator

610-277-8073

Gadolin Research ( Site 1032)

Recruiting

Beaumont, Texas, United States, 77702

Contacts

Study Coordinator

409-331-6040

Horizon Clinical Research Center - Houston ( Site 1026)

Recruiting

Cypress, Texas, United States, 77429

Contacts

Study Coordinator

949-491-0710

Ottawa Memory Clinic ( Site 2001)

Recruiting

Ottawa, Ontario, Canada, K1Z 1G3

Contacts

Study Coordinator

613-702-1000

Sunnybrook Research Institute ( Site 2003)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

4164804551

Toronto Western Hospital ( Site 2004)

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Study Coordinator

4166032581

Clinique Mémoire de Montreal ( Site 2000)

Recruiting

Montreal, Quebec, Canada, H3G 1H9

Contacts

Study Coordinator

5144003903

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-26.