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

May 22, 2026 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Caba, Argentina, C1428AQK
        • Recruiting
        • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +541157773200
    • Buenos Aires F.D.
      • Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1015ABO
        • Recruiting
        • Organizacion Medica de Investigacion ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491143720308
      • Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +5401152990000
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • Southern Neurology ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +61408455183
      • Macquarie Park, New South Wales, Australia, 2113
        • Recruiting
        • KARA Institute for Neurological Diseases ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +61289607788
    • Victoria
      • Ivanhoe, Victoria, Australia, 3079
        • Recruiting
        • Austin Health ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: 61394962181
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • HammondCare ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +61395976568
  • Belgium
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +3227641779
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 3000)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 16 34 75 90
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • Recruiting
        • AZ Groeninge Campus Kennedylaan ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +3256636363
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recruiting
        • Ottawa Memory Clinic ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 613-702-1000
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: 4166032581
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 4164804551
    • Quebec
      • Montreal, Quebec, Canada, H3G 1H9
        • Recruiting
        • Clinique Mémoire de Montreal ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: 5144003903
  • Japan
      • Chiba, Japan, 263-0043
        • Recruiting
        • Inage Neurology and Memory Clinic ( Site 9001)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-43-307-8500
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital ( Site 9010)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-642-5774
      • Okayama, Japan, 700-8557
        • Recruiting
        • Okayama City General Medical Center Okayama City Hospital ( Site 9008)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-737-3000
    • Aichi-ken
      • Ōbu, Aichi-ken, Japan, 474-8511
        • Recruiting
        • National Center for Geriatrics and Gerontology ( Site 9002)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-46-2311
    • Chiba
      • Narashino, Chiba, Japan, 275-8580
        • Recruiting
        • Chibaken Saiseikai Narashino Hospital ( Site 9000)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-47-473-1281
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 210-0852
        • Recruiting
        • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-366-8900
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital ( Site 9011)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-59-231-5246
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 710-0813
        • Recruiting
        • Katayama Medical Clinic ( Site 9005)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-422-0753
    • Saga-ken
      • Kanzaki-gun, Saga-ken, Japan, 8420192
        • Recruiting
        • National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-952-52-3231
    • Tokyo
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 9003)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
  • Netherlands
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
        • Recruiting
        • Brain Research Center Den Bosch B.V. ( Site 5001)
        • Contact:
          • Study Coordinator
          • Phone Number: +0203017170
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 GN
        • Recruiting
        • Brain Research Center. ( Site 5000)
        • Contact:
          • Study Coordinator
          • Phone Number: +0203017170
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AZ
        • Recruiting
        • Brain Research Center Zwolle ( Site 5002)
        • Contact:
          • Study Coordinator
          • Phone Number: +0203017170
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +6562566011
  • South Korea
      • Seoul, South Korea, 07804
        • Recruiting
        • Ewha Womans University Seoul Hospital ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: +82269861792
      • Seoul, South Korea, 04763
        • Recruiting
        • Hanyang University Hospital ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222908374
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234101233
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar ( Site 6001)
        • Contact:
          • Study Coordinator
          • Phone Number: +34933160778
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial ( Site 6002)
        • Contact:
          • Study Coordinator
          • Phone Number: +34626001165
    • Barcelona
      • Terrassa, Barcelona, Spain, 08222
        • Recruiting
        • Hospital Universitari Mutua Terrassa ( Site 6004)
        • Contact:
          • Study Coordinator
          • Phone Number: +34937365050
    • Catalonia
      • Barcelona, Catalonia, Spain, 08028
        • Recruiting
        • Fundació ACE ( Site 6003)
        • Contact:
          • Study Coordinator
          • Phone Number: +34677440680
  • United Kingdom
      • Birmingham, United Kingdom, B16 8LT
        • Recruiting
        • Re:Cognition Health - Birmingham ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 0121 655 016
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2XE
        • Recruiting
        • Scottish Brain Sciences Aberdeen ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: +4401313530233
    • Edinburgh, City of
      • Edinburgh, Edinburgh, City of, United Kingdom, EH12 5PJ
        • Recruiting
        • Scottish Brain Sciences ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: +4401313530233
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO30 3JB
        • Recruiting
        • Moorgreen Hospital ( Site 8004)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 (0) 2382318757
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 3448 4531
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Recruiting
        • Warneford Hospital ( Site 8007)
        • Contact:
          • Study Coordinator
          • Phone Number: +441865902135
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • Recruiting
        • Remind UK ( Site 8003)
        • Contact:
          • Study Coordinator
          • Phone Number: 01225 476420
  • United States
    • California
      • Irvine, California, United States, 92614
        • Recruiting
        • Irvine Clinical Research ( Site 1041)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-753-1663
      • Long Beach, California, United States, 90804
        • Recruiting
        • Healthy Brain Clinic ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 562-606-5999
      • Los Angeles, California, United States, 90056
        • Recruiting
        • Inglewood Clinical ( Site 1062)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-265-1612
      • Redlands, California, United States, 92374
        • Recruiting
        • Anderson Clinical Research ( Site 1024)
        • Contact:
          • Study Coordinator
          • Phone Number: 909-792-9007
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Memory and Aging Center ( Site 1031)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-353-3585
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-542-3008
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University, Alzheimer's Disease Research Unit ( Site 1059)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-764-8100
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JEM Research Institute ( Site 1046)
        • Contact:
          • Study Coordinator
          • Phone Number: 561-968-2933
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Neuropsychiatric Research Center of Southwest Florida ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 239-939-7777
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Indago Research & Health Center, Inc ( Site 1044)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-825-6588
      • Maitland, Florida, United States, 32750
        • Recruiting
        • K2 Medical Research ( Site 1047)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-500-5252
      • Melbourne, Florida, United States, 32940
        • Recruiting
        • ClinCloud LLC ( Site 1039)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-680-0534
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research ( Site 1035)
        • Contact:
          • Study Coordinator
          • Phone Number: 239-529-6780
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-849-4131
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Renstar Medical Research ( Site 1012)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-629-5800
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research - Orlando ( Site 1051)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-337-3000
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Axiom Brain Health ( Site 1029)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-353-9613
      • Tampa, Florida, United States, 33634
        • Recruiting
        • K2 Medical Research ( Site 1020)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-800-5252
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake ( Site 1019)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-775-1000
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research LLC ( Site 1053)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-916-0060
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC ( Site 1015)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-537-1281
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • Alexian Brothers Medical Center-Neurosciences ( Site 1017)
        • Contact:
          • Study Coordinator
          • Phone Number: 847-593-8553
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Boston Center for Memory ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-699-6927
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Recruiting
        • Clinical Research Professionals ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: 636-220-1200
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064)
        • Contact:
          • Study Coordinator
          • Phone Number: 201-850-4622
      • Springfield, New Jersey, United States, 07081
        • Recruiting
        • The Cognitive and Research Center of NJ ( Site 1057)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-850-4622
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • CenExel- AMRI ( Site 1018)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-341-9500
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Alzheimer Disease Research Center (ADRC) ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: 518-426-0575
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Mid Hudson Medical Research ( Site 1050)
        • Contact:
          • Study Coordinator
          • Phone Number: 845-674-9398
      • Queens, New York, United States, 11413
        • Recruiting
        • Basil Clinical ( Site 1065)
        • Contact:
          • Study Coordinator
          • Phone Number: 917-672-3275
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • AMC Research, LLC ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: 704-364-4000
    • Ohio
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Insight Clinical Trials ( Site 1011)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-245-6556
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research ( Site 1028)
        • Contact:
          • Study Coordinator
          • Phone Number: 330-493-1118
    • Pennsylvania
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Recruiting
        • Flourish Research ( Site 1048)
        • Contact:
          • Study Coordinator
          • Phone Number: 610-277-8073
    • Texas
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Gadolin Research ( Site 1032)
        • Contact:
          • Study Coordinator
          • Phone Number: 409-331-6040
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Horizon Clinical Research Center - Houston ( Site 1026)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-491-0710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-2214
Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study.
Biological: MK-2214
IV infusion
Placebo Comparator: Placebo
Participants will receive a placebo via IV infusion q4w during the study.
Drug: Placebo
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)
Time Frame: Baseline, up to approximately 23 months
Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD & damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported.
Baseline, up to approximately 23 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 26 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported.
Up to approximately 26 months
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 23 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score
Time Frame: Baseline, up to approximately 23 months
The CDR-SB is used for cognitive assessment in people with AD. The CDR is a clinical scale that describes 5 degrees of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia CDR score ranging from 0 (normal) to 3 (severe). A total score is calculated as the sum of the category scores, with a range of 0 (normal) to 18 (severe). Higher scores indicate more impairment. The change from baseline in CDR-SB total score will be reported.
Baseline, up to approximately 23 months
Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV
Time Frame: Baseline, up to approximately 23 months
Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD & damages brain cells. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from Braak I to VI. Description for Braak III includes amygdala, parahippocampal gyrus, fusiform gyrus, & lingual gyrus, and Braak IV includes insula, inferior temporal, lateral temporal, posterior cingulate, & inferior parietal. The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr in Braak regions III and IV will be reported.
Baseline, up to approximately 23 months
Change from Baseline in the Composite Tau PET SUVr
Time Frame: Baseline, up to approximately 23 months
Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD & damages brain cells. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr will be reported.
Baseline, up to approximately 23 months
Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI
Time Frame: Baseline, up to approximately 23 months
Participants will have tau PET imaging to assess tau (protein that accumulates in AD & damages brain cells) pathology. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from I-VI (Braak I (transentorhinal); II (entorhinal & hippocampus); III (amygdala, parahippocampal gyrus, fusiform gyrus, & lingual gyrus); IV (insula, inferior temporal, lateral temporal, posterior cingulate, & inferior parietal); V (orbitofrontal, superior temporal, inferior frontal, cuneus, anterior cingulate, supramarginal gyrus, lateral occipital, precuneus, superior parietal, superior frontal, & rostro medial frontal); VI (paracentral, postcentral, precentral, & pericalcarine)). Composite tau PET SUVr is weighted average of tau PET SUVr values from multiple brain regions, with weights being percentage volume of each region. The change from baseline in composite tau PET SUVr in Braak region I to IV will be reported.
Baseline, up to approximately 23 months
Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score
Time Frame: Baseline, up to approximately 23 months
The ADAS-Cog13 is a structured scale that evaluates memory (word recall, delayed word recall, and word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). In addition, ratings of spoken language, language comprehension, word finding difficulty, ability to remember test instructions, and number cancellation will be obtained. Per protocol, score range will be from 0 (no impairment) to 85 (maximum impairment) points. Higher scores indicate more impairment. The change from baseline in ADAS-Cog13 total score will be reported.
Baseline, up to approximately 23 months
Change from Baseline in the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI) Total Score
Time Frame: Baseline, up to approximately 23 months
ADCS-ADL-MCI evaluates the ability of individuals to perform various daily activities including basic activities of daily living (BADL; personal care tasks like bathing, dressing and eating) and instrumental activities of daily living (IADL; complex tasks such as managing finances, preparing meals, using telephone) administered through caregiver or family member to access severity of cognitive decline in the past 4 weeks. Each item is scored on a scale of 0 (unable to do) to 2 (independent). The total score is calculated by summing scores of all items and ranges from 0 (poor functioning) to 68 (better functioning). Higher scores indicate better functional ability. The change from baseline in ADCS-ADL-MCI total score will be reported.
Baseline, up to approximately 23 months
Change from Baseline in Modified Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score
Time Frame: Baseline, up to approximately 23 months
The modified iADRS is a composite tool to measure cognition and function. The modified iADRS is a linear combination of total scores from the ADAS-Cog and the ADCS-ADL-MCI. The modified iADRS composite score is calculated by subtracting the ADAS-Cog13 score from 85 and then adding the ADCS-ADL-MCI score. Composite score ranges from 0 (maximum impairment) to 144 (greater independent, healthy functioning and cognition). Lower scores indicate more impairment. The change from baseline in modified iADRS total score will be reported.
Baseline, up to approximately 23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

June 13, 2025

First Submitted That Met QC Criteria

June 13, 2025

First Posted (Actual)

June 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2214-004
  • MK-2214-004 (Other Identifier: MSD)
  • 2024-519190-19-00 (Registry Identifier: EU CT)
  • U1111-1314-8296 (Registry Identifier: UTN)
  • jRCT2031250299 (Registry Identifier: Japan Registry of Clinical Trial (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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