A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
Purpose
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
Condition
- Early Alzheimer's Disease
Eligibility
- Eligible Ages
- Between 50 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Inglewood 5359488, California 5332921 90301
Study Coordinator
949-265-1612
Irvine 5359777, California 5332921 92614
Study Coordinator
949-753-1663
Long Beach 5367929, California 5332921 90804
Study Coordinator
562-606-5999
Redlands 5386754, California 5332921 92374
Study Coordinator
909-792-9007
San Francisco 5391959, California 5332921 94158
Study Coordinator
415-353-3585
Santa Ana 5392900, California 5332921 92705
Study Coordinator
714-542-3008
New Haven 4839366, Connecticut 4831725 06510
Study Coordinator
203-764-8100
Atlantis 4146372, Florida 4155751 33462
Study Coordinator
561-968-2933
Fort Myers 4155995, Florida 4155751 33912
Study Coordinator
239-939-7777
Maitland 4163220, Florida 4155751 32750
Study Coordinator
407-500-5252
Melbourne 4163971, Florida 4155751 32940
Study Coordinator
407-680-0534
Naples 4165565, Florida 4155751 34105
Study Coordinator
239-529-6780
New Port Richey 4165869, Florida 4155751 34652
Study Coordinator
727-849-4131
Ocala 4166673, Florida 4155751 34471
Study Coordinator
352-629-5800
Orlando 4167147, Florida 4155751 32803
Study Coordinator
407-337-3000
Tampa 4174757, Florida 4155751 33607
Study Coordinator
813-800-5252
Tampa 4174757, Florida 4155751 33609
Study Coordinator
813-353-9613
The Villages 4175179, Florida 4155751 32162
Study Coordinator
352-775-1000
Winter Park 4178560, Florida 4155751 32789
Study Coordinator
407-916-0060
Decatur 4191124, Georgia 4197000 30030
Study Coordinator
404-537-1281
Elk Grove Village 4890925, Illinois 4896861 60007
Study Coordinator
847-593-8553
Newton 4945283, Massachusetts 6254926 02459
Study Coordinator
617-699-6927
Chesterfield 4381072, Missouri 4398678 63005
Study Coordinator
636-220-1200
Ridgewood 5103269, New Jersey 5101760 07450
Study Coordinator
201-850-4622
Springfield 5104952, New Jersey 5101760 07081
Study Coordinator
973-850-4622
Toms River 4504476, New Jersey 5101760 08755
Study Coordinator
732-341-9500
Albany 5106834, New York 5128638 12208
Study Coordinator
518-426-0575
New Windsor 5128577, New York 5128638 12553
Study Coordinator
845-674-9398
Queens 5133273, New York 5128638 11413
Study Coordinator
917-672-3275
Independence 5158404, Ohio 5165418 44131
Study Coordinator
216-245-6556
North Canton 5164706, Ohio 5165418 44720
Study Coordinator
330-493-1118
Plymouth Meeting 5206666, Pennsylvania 6254927 19462
Study Coordinator
610-277-8073
Beaumont 4672989, Texas 4736286 77702
Study Coordinator
409-331-6040
Cypress 4684724, Texas 4736286 77429
Study Coordinator
949-491-0710
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC