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

RecruitingPhase 2

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

Who can join

Ages 50 to 85 · All sexes

Full 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

About the 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

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 340 · Started: Jul 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07033494

Locations in the U.S.

CaliforniaIrvine Clinical Research ( Site 1041), Irvine
Healthy Brain Clinic ( Site 1005), Long Beach
Inglewood Clinical ( Site 1062), Los Angeles
Anderson Clinical Research ( Site 1024), Redlands
UCSF Memory and Aging Center ( Site 1031), San Francisco
Syrentis Clinical Research ( Site 1001), Santa Ana
ConnecticutYale University, Alzheimer's Disease Research Unit ( Site 1059), New Haven
FloridaJEM Research Institute ( Site 1046), Atlantis
Neuropsychiatric Research Center of Southwest Florida ( Site 1003), Fort Myers
K2 Medical Research ( Site 1047), Maitland
ClinCloud LLC ( Site 1039), Melbourne
Indago Research and Health Center Inc ( Site 1044), Miami Lakes
Aqualane Clinical Research ( Site 1035), Naples
Suncoast Clinical Research ( Site 1007), New Port Richey
Renstar Medical Research ( Site 1012), Ocala
Charter Research - Orlando ( Site 1051), Orlando
Axiom Brain Health ( Site 1029), Tampa
K2 Medical Research ( Site 1020), Tampa
Charter Research - Lady Lake ( Site 1019), The Villages
Conquest Research LLC ( Site 1053), Winter Park
GeorgiaCenExel iResearch, LLC ( Site 1015), Decatur
IllinoisAlexian Brothers Medical Center-Neurosciences ( Site 1017), Elk Grove Village
MassachusettsBoston Center for Memory ( Site 1008), Newton
MissouriClinical Research Professionals ( Site 1004), Chesterfield
New JerseyThe Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064), Ridgewood
The Cognitive and Research Center of NJ ( Site 1057), Springfield
CenExel- AMRI ( Site 1018), Toms River
New YorkAlzheimer Disease Research Center (ADRC) ( Site 1000), Albany
Mid Hudson Medical Research ( Site 1050), New Windsor
Basil Clinical ( Site 1065), Queens
North CarolinaAMC Research, LLC ( Site 1006), Matthews
OhioInsight Clinical Trials ( Site 1011), Independence
Neuro-Behavioral Clinical Research ( Site 1028), North Canton
PennsylvaniaFlourish Research ( Site 1048), Plymouth Meeting
TexasGadolin Research ( Site 1032), Beaumont
Horizon Clinical Research Center - Houston ( Site 1026), Cypress

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.