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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519190-19-00
Acronym
MK-2214-004
Enrollment
58
Registered
2025-09-30
Start date
2025-10-03
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s Disease

Brief summary

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

Detailed description

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

Interventions

DRUGPlacebo to MK-2214

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026