A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
Part of paid clinical trials in Irvine, California.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT07033494
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Early Alzheimer's Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- MK-2214 — BIOLOGICALIV infusion
- Placebo — DRUGIV infusion
Study Details
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 Dates
- Start date
- Jul 16, 2025
- Status verified
- May 2026
- Primary completion
- Apr 30, 2029
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 340 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: MK-2214Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study.
- Placebo Comparator: PlaceboParticipants will receive a placebo via IV infusion q4w during the study.
Primary Outcome Measure
Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr) [ Time Frame: Baseline, up to approximately 23 months ]
Central Contacts
- Toll Free Number1-888-577-8839
Locations (36)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Irvine Clinical Research ( Site 1041) | Irvine | California | 92614 | Study Coordinator 949-753-1663 |
| Healthy Brain Clinic ( Site 1005) | Long Beach | California | 90804 | Study Coordinator 562-606-5999 |
| Inglewood Clinical ( Site 1062) | Los Angeles | California | 90056 | Study Coordinator 949-265-1612 |
| Anderson Clinical Research ( Site 1024) | Redlands | California | 92374 | Study Coordinator 909-792-9007 |
| UCSF Memory and Aging Center ( Site 1031) | San Francisco | California | 94158 | Study Coordinator 415-353-3585 |
| Syrentis Clinical Research ( Site 1001) | Santa Ana | California | 92705 | Study Coordinator 714-542-3008 |
| Yale University, Alzheimer's Disease Research Unit ( Site 1059) | New Haven | Connecticut | 06510 | Study Coordinator 203-764-8100 |
| JEM Research Institute ( Site 1046) | Atlantis | Florida | 33462 | Study Coordinator 561-968-2933 |
| Neuropsychiatric Research Center of Southwest Florida ( Site 1003) | Fort Myers | Florida | 33912 | Study Coordinator 239-939-7777 |
| Indago Research & Health Center, Inc ( Site 1044) | Hialeah | Florida | 33012 | Study Coordinator 305-825-6588 |
| K2 Medical Research ( Site 1047) | Maitland | Florida | 32750 | Study Coordinator 407-500-5252 |
| ClinCloud LLC ( Site 1039) | Melbourne | Florida | 32940 | Study Coordinator 407-680-0534 |
| Aqualane Clinical Research ( Site 1035) | Naples | Florida | 34105 | Study Coordinator 239-529-6780 |
| Suncoast Clinical Research ( Site 1007) | New Port Richey | Florida | 34652 | Study Coordinator 727-849-4131 |
| Renstar Medical Research ( Site 1012) | Ocala | Florida | 34471 | Study Coordinator 352-629-5800 |
| Charter Research - Orlando ( Site 1051) | Orlando | Florida | 32803 | Study Coordinator 407-337-3000 |
| Axiom Brain Health ( Site 1029) | Tampa | Florida | 33609 | Study Coordinator 813-353-9613 |
| K2 Medical Research ( Site 1020) | Tampa | Florida | 33634 | Study Coordinator 813-800-5252 |
| Charter Research - Lady Lake ( Site 1019) | The Villages | Florida | 32162 | Study Coordinator 352-775-1000 |
| Conquest Research LLC ( Site 1053) | Winter Park | Florida | 32789 | Study Coordinator 407-916-0060 |
| CenExel iResearch, LLC ( Site 1015) | Decatur | Georgia | 30030 | Study Coordinator 404-537-1281 |
| Alexian Brothers Medical Center-Neurosciences ( Site 1017) | Elk Grove Village | Illinois | 60007 | Study Coordinator 847-593-8553 |
| Boston Center for Memory ( Site 1008) | Newton | Massachusetts | 02459 | Study Coordinator 617-699-6927 |
| Clinical Research Professionals ( Site 1004) | Chesterfield | Missouri | 63005 | Study Coordinator 636-220-1200 |
| The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064) | Ridgewood | New Jersey | 07450 | Study Coordinator 201-850-4622 |
| The Cognitive and Research Center of NJ ( Site 1057) | Springfield | New Jersey | 07081 | Study Coordinator 973-850-4622 |
| CenExel- AMRI ( Site 1018) | Toms River | New Jersey | 08755 | Study Coordinator 732-341-9500 |
| Alzheimer Disease Research Center (ADRC) ( Site 1000) | Albany | New York | 12208 | Study Coordinator 518-426-0575 |
| Mid Hudson Medical Research ( Site 1050) | New Windsor | New York | 12553 | Study Coordinator 845-674-9398 |
| Basil Clinical ( Site 1065) | Queens | New York | 11413 | Study Coordinator 917-672-3275 |
| AMC Research, LLC ( Site 1006) | Matthews | North Carolina | 28105 | Study Coordinator 704-364-4000 |
| Insight Clinical Trials ( Site 1011) | Independence | Ohio | 44131 | Study Coordinator 216-245-6556 |
| Neuro-Behavioral Clinical Research ( Site 1028) | North Canton | Ohio | 44720 | Study Coordinator 330-493-1118 |
| Flourish Research ( Site 1048) | Plymouth Meeting | Pennsylvania | 19462 | Study Coordinator 610-277-8073 |
| Gadolin Research ( Site 1032) | Beaumont | Texas | 77702 | Study Coordinator 409-331-6040 |
| Horizon Clinical Research Center - Houston ( Site 1026) | Cypress | Texas | 77429 | Study Coordinator 949-491-0710 |
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