Actively Recruiting
A Phase 2 Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-2214 in Early Alzheimer's Disease
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26
340
Participants Needed
78
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimer's disease (AD), a condition that causes memory loss, speech difficulties, and problems with decision-making. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the treatment's safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous (IV) infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.
CONDITIONS
Brief Title
A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 to 85 years
- Have mild cognitive impairment or mild dementia due to Alzheimer's disease
- Have a designated study partner who can support participation
- If on approved Alzheimer's therapy, dosing must be stable for at least 3 months before screening
You will not qualify if you...
- History of stroke or cerebrovascular disease
- Diagnosis of other central nervous system diseases affecting cognition
- Structural brain disease
- History of seizures or epilepsy within 5 years before screening
- Major brain trauma or infections affecting brain function
- Major or unstable medical illness within 3 months before screening
- Severe acute or chronic medical or psychiatric conditions or lab abnormalities
- Uncontrolled immunological disease or requiring biologic/immunosuppressant treatment
- Uncontrolled bleeding disorders
- History of cancer within 5 years before screening
- Risk factors for QT interval prolongation
- Liver disease
- Unable or unwilling to undergo CT, PET, or MRI scans
- Living in nursing home or assisted care with continuous medical supervision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 23 months
Participants receive MK-2214 or placebo via intravenous (IV) infusion every 4 weeks during the study.
Infusions every 4 weeks
Trial Site Locations
Total: 78 locations
1
Irvine Clinical Research ( Site 1041)
Irvine, California, United States, 92614
Actively Recruiting
2
Healthy Brain Clinic ( Site 1005)
Long Beach, California, United States, 90804
Actively Recruiting
3
Inglewood Clinical ( Site 1062)
Los Angeles, California, United States, 90056
Actively Recruiting
4
Anderson Clinical Research ( Site 1024)
Redlands, California, United States, 92374
Actively Recruiting
5
UCSF Memory and Aging Center ( Site 1031)
San Francisco, California, United States, 94158
Actively Recruiting
6
Syrentis Clinical Research ( Site 1001)
Santa Ana, California, United States, 92705
Actively Recruiting
7
Yale University, Alzheimer's Disease Research Unit ( Site 1059)
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
JEM Research Institute ( Site 1046)
Atlantis, Florida, United States, 33462
Actively Recruiting
9
Neuropsychiatric Research Center of Southwest Florida ( Site 1003)
Fort Myers, Florida, United States, 33912
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10
Indago Research & Health Center, Inc ( Site 1044)
Hialeah, Florida, United States, 33012
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11
K2 Medical Research ( Site 1047)
Maitland, Florida, United States, 32750
Actively Recruiting
12
ClinCloud LLC ( Site 1039)
Melbourne, Florida, United States, 32940
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13
Aqualane Clinical Research ( Site 1035)
Naples, Florida, United States, 34105
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14
Suncoast Clinical Research ( Site 1007)
New Port Richey, Florida, United States, 34652
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15
Renstar Medical Research ( Site 1012)
Ocala, Florida, United States, 34471
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16
Charter Research - Orlando ( Site 1051)
Orlando, Florida, United States, 32803
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17
Axiom Brain Health ( Site 1029)
Tampa, Florida, United States, 33609
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18
K2 Medical Research ( Site 1020)
Tampa, Florida, United States, 33634
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19
Charter Research - Lady Lake ( Site 1019)
The Villages, Florida, United States, 32162
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20
Conquest Research LLC ( Site 1053)
Winter Park, Florida, United States, 32789
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21
CenExel iResearch, LLC ( Site 1015)
Decatur, Georgia, United States, 30030
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22
Alexian Brothers Medical Center-Neurosciences ( Site 1017)
Elk Grove Village, Illinois, United States, 60007
Actively Recruiting
23
Boston Center for Memory ( Site 1008)
Newton, Massachusetts, United States, 02459
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24
Clinical Research Professionals ( Site 1004)
Chesterfield, Missouri, United States, 63005
Actively Recruiting
25
The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064)
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
26
The Cognitive and Research Center of NJ ( Site 1057)
Springfield, New Jersey, United States, 07081
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27
CenExel- AMRI ( Site 1018)
Toms River, New Jersey, United States, 08755
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28
Alzheimer Disease Research Center (ADRC) ( Site 1000)
Albany, New York, United States, 12208
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29
Mid Hudson Medical Research ( Site 1050)
New Windsor, New York, United States, 12553
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30
Basil Clinical ( Site 1065)
Queens, New York, United States, 11413
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31
AMC Research, LLC ( Site 1006)
Matthews, North Carolina, United States, 28105
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32
Insight Clinical Trials ( Site 1011)
Independence, Ohio, United States, 44131
Actively Recruiting
33
Neuro-Behavioral Clinical Research ( Site 1028)
North Canton, Ohio, United States, 44720
Actively Recruiting
34
Flourish Research ( Site 1048)
Plymouth Meeting, Pennsylvania, United States, 19462
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35
Gadolin Research ( Site 1032)
Beaumont, Texas, United States, 77702
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36
Horizon Clinical Research Center - Houston ( Site 1026)
Cypress, Texas, United States, 77429
Actively Recruiting
37
Organizacion Medica de Investigacion ( Site 0401)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1015ABO
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38
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
Actively Recruiting
39
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400)
Caba, Argentina, C1428AQK
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40
Southern Neurology ( Site 0306)
Kogarah, New South Wales, Australia, 2217
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41
KARA Institute for Neurological Diseases ( Site 0302)
Macquarie Park, New South Wales, Australia, 2113
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42
Austin Health ( Site 0300)
Ivanhoe, Victoria, Australia, 3079
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43
HammondCare ( Site 0301)
Malvern, Victoria, Australia, 3144
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44
Cliniques universitaires Saint-Luc ( Site 3001)
Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
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45
UZ Leuven ( Site 3000)
Leuven, Vlaams-Brabant, Belgium, 3000
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46
AZ Groeninge Campus Kennedylaan ( Site 3002)
Kortrijk, West-Vlaanderen, Belgium, 8500
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47
Ottawa Memory Clinic ( Site 2001)
Ottawa, Ontario, Canada, K1Z 1G3
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48
Sunnybrook Research Institute ( Site 2003)
Toronto, Ontario, Canada, M4N 3M5
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49
Toronto Western Hospital ( Site 2004)
Toronto, Ontario, Canada, M5T 2S8
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50
Clinique Mémoire de Montreal ( Site 2000)
Montreal, Quebec, Canada, H3G 1H9
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51
National Center for Geriatrics and Gerontology ( Site 9002)
Ōbu, Aichi-ken, Japan, 474-8511
Actively Recruiting
52
Chibaken Saiseikai Narashino Hospital ( Site 9000)
Narashino, Chiba, Japan, 275-8580
Actively Recruiting
53
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016)
Kawasaki, Kanagawa, Japan, 210-0852
Actively Recruiting
54
Mie University Hospital ( Site 9011)
Tsu, Mie-ken, Japan, 514-8507
Actively Recruiting
55
Katayama Medical Clinic ( Site 9005)
Kurashiki, Okayama-ken, Japan, 710-0813
Actively Recruiting
56
National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004)
Kanzaki-gun, Saga-ken, Japan, 8420192
Actively Recruiting
57
Tokyo Medical University Hospital ( Site 9003)
Shinjuku, Tokyo, Japan, 160-0023
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58
Inage Neurology and Memory Clinic ( Site 9001)
Chiba, Japan, 263-0043
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59
Kyushu University Hospital ( Site 9010)
Fukuoka, Japan, 812-8582
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60
Okayama City General Medical Center Okayama City Hospital ( Site 9008)
Okayama, Japan, 700-8557
Actively Recruiting
61
Brain Research Center Den Bosch B.V. ( Site 5001)
's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
Actively Recruiting
62
Brain Research Center. ( Site 5000)
Amsterdam, North Holland, Netherlands, 1081 GN
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63
Brain Research Center Zwolle ( Site 5002)
Zwolle, Overijssel, Netherlands, 8025 AZ
Actively Recruiting
64
Tan Tock Seng Hospital ( Site 0102)
Singapore, Central Singapore, Singapore, 308433
Actively Recruiting
65
Hanyang University Hospital ( Site 0200)
Seoul, South Korea, 04763
Actively Recruiting
66
Samsung Medical Center ( Site 0202)
Seoul, South Korea, 06351
Actively Recruiting
67
Ewha Womans University Seoul Hospital ( Site 0201)
Seoul, South Korea, 07804
Actively Recruiting
68
Hospital Universitari Mutua Terrassa ( Site 6004)
Terrassa, Barcelona, Spain, 08222
Actively Recruiting
69
Fundació ACE ( Site 6003)
Barcelona, Catalonia, Spain, 08028
Actively Recruiting
70
Hospital del Mar ( Site 6001)
Barcelona, Spain, 08003
Actively Recruiting
71
Hospital Clinic i Provincial ( Site 6002)
Barcelona, Spain, 08036
Actively Recruiting
72
Scottish Brain Sciences Aberdeen ( Site 8001)
Aberdeen, Aberdeen City, United Kingdom, AB25 2XE
Actively Recruiting
73
Scottish Brain Sciences ( Site 8000)
Edinburgh, Edinburgh, City of, United Kingdom, EH12 5PJ
Actively Recruiting
74
Moorgreen Hospital ( Site 8004)
Southampton, Hampshire, United Kingdom, SO30 3JB
Actively Recruiting
75
Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006)
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
76
Warneford Hospital ( Site 8007)
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Actively Recruiting
77
Remind UK ( Site 8003)
Bath, Somerset, United Kingdom, BA1 3NG
Actively Recruiting
78
Re:Cognition Health - Birmingham ( Site 8002)
Birmingham, United Kingdom, B16 8LT
Actively Recruiting
Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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