A clinical study of MK-2214 in people with Alzheimer’s disease (MK-2214-004)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

3 Oct 2025 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-519190-19-00

WHO UTN

U1111-1314-8296

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Therapy, Pharmacokinetic, Others

1. To compare the efficacy of MK-2214 versus placebo in slowing the progression of tau spreading, as measured by the change from baseline in tau positron emission tomography (PET) standardized uptake value ratio (SUVr).
2. To evaluate the safety and tolerability of MK-2214.

Secondary objectives 7

1. To compare the efficacy of MK-2214 versus placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
2. To compare the efficacy of MK-2214 versus placebo in slowing the progression of tau spreading, as measured by the change from baseline in the composite tau PET SUVr in Braak region III and IV.
3. To compare the efficacy of MK-2214 versus placebo in slowing the progression of tau spreading, as measured by the change from baseline in the composite tau PET SUVr.
4. To compare the efficacy of MK-2214 versus placebo in slowing the progression of tau spreading, as measured by the PET SUVr in Braak region I to VI.
5. To evaluate the efficacy of MK-2214 versus placebo on the change from baseline in the AD Assessment Scale–Cognitive Subscale13 (ADAS-Cog13) Total Score.
6. To evaluate the efficacy of MK-2214 versus placebo on the change from baseline in the Alzheimer’s Disease Cooperative Study Activities of Daily Living for mild cognitive impairment (ADCS-ADL-MCI) score.
7. To evaluate the efficacy of MK-2214 versus placebo on the change from baseline in modified integrated Alzheimer’s Disease Rating Scale (iADRS) score.

Conditions and MedDRA coding

Alzheimer’s Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s Disease (AD)
2. Has a designated study partner who can fulfill the requirements of this study
3. If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to Screening

Exclusion criteria 14

1. Has a known history of stroke or cerebrovascular disease
2. Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically
3. Has structural brain disease
4. Has a history of seizures or epilepsy within 5 years before Screening
5. Has any other major central nervous system trauma, or infections that affect brain function
6. Has major medical illness or unstable medical condition within 3 months before Screening
7. Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
8. Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study
9. Has a bleeding disorder that is not under adequate control
10. Has a history of malignancy occurring within 5 years of screening
11. Has a risk factor for Corrected QT interval (QTc) prolongation
12. Has liver disease
13. Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan
14. Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Change from Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
2. Number of Participants Who Experience One or More Adverse Events (AEs)
3. Number of Participants Who Discontinue Study Intervention Due to an AE

Secondary endpoints 7

1. Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score
2. Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV
3. Change from Baseline in the Composite Tau PET SUVr
4. Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI
5. Change from Baseline in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale13 (ADAS-Cog13) Total Score
6. Change from Baseline in the Alzheimer’s Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI) Total Score
7. Change from Baseline in Modified Integrated Alzheimer’s Disease Rating Scale (iADRS) Total Score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Claudia Kaiser-Albers

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Claudia Kaiser-Albers

Third parties 9

Locations

3 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications