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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Early Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT07033494

Run by

Merck Sharp & Dohme LLC

People needed

340

Starts

2025-07-16

Expected to finish

2029-04-30

Last updated by the study team

2026-07-06

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Healthy Brain Clinic ( Site 1005) — Long Beach, California, United States (enrolling)
• Inglewood Clinical ( Site 1062) — Los Angeles, California, United States (enrolling)
• Anderson Clinical Research ( Site 1024) — Redlands, California, United States (enrolling)
• UCSF Memory and Aging Center ( Site 1031) — San Francisco, California, United States (enrolling)
• Syrentis Clinical Research ( Site 1001) — Santa Ana, California, United States (enrolling)
• Yale University, Alzheimer's Disease Research Unit ( Site 1059) — New Haven, Connecticut, United States (enrolling)
• JEM Research Institute ( Site 1046) — Atlantis, Florida, United States (enrolling)
• Neuropsychiatric Research Center of Southwest Florida ( Site 1003) — Fort Myers, Florida, United States (enrolling)
• K2 Medical Research ( Site 1047) — Maitland, Florida, United States (enrolling)
• ClinCloud LLC ( Site 1039) — Melbourne, Florida, United States (enrolling)
• Indago Research and Health Center Inc ( Site 1044) — Miami Lakes, Florida, United States (enrolling)
• Aqualane Clinical Research ( Site 1035) — Naples, Florida, United States (enrolling)
• Suncoast Clinical Research ( Site 1007) — New Port Richey, Florida, United States (enrolling)
• Renstar Medical Research ( Site 1012) — Ocala, Florida, United States (enrolling)
• Charter Research - Orlando ( Site 1051) — Orlando, Florida, United States (enrolling)
• Axiom Brain Health ( Site 1029) — Tampa, Florida, United States (enrolling)
• K2 Medical Research ( Site 1020) — Tampa, Florida, United States (enrolling)
• Charter Research - Lady Lake ( Site 1019) — The Villages, Florida, United States (enrolling)
• Conquest Research LLC ( Site 1053) — Winter Park, Florida, United States (enrolling)
• CenExel iResearch, LLC ( Site 1015) — Decatur, Georgia, United States (enrolling)
• Alexian Brothers Medical Center-Neurosciences ( Site 1017) — Elk Grove Village, Illinois, United States (enrolling)
• Boston Center for Memory ( Site 1008) — Newton, Massachusetts, United States (enrolling)
• Clinical Research Professionals ( Site 1004) — Chesterfield, Missouri, United States (enrolling)
• The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064) — Ridgewood, New Jersey, United States (enrolling)
• Irvine Clinical Research ( Site 1041) — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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