A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy and Safety of MK-1167 as Adjunctive Therapy in Participants with Mild to Moderate Alzheimer’s Disease Dementia

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

1 Apr 2025 → 28 May 2026

Decision date (initial)

2025-03-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-515539-31-00

WHO UTN

U1111-1309-3391

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Dose response, Pharmacokinetic, Pharmacogenetic, Pharmacogenomic, Safety

1. To assess the efficacy of MK-1167 as adjunctive therapy to acetylcholinesterase inhibitors on the ADAS-Cog11 Total Score compared with placebo at Week 24.
2. To evaluate the safety and tolerability of MK-1167 as adjunctive therapy to acetylcholinesterase inhibitors.

Secondary objectives 5

1. To assess the efficacy of MK-1167 as adjunctive therapy to acetylcholinesterase inhibitors on the ADCS-CGIC Overall Score compared with placebo at Week 24.
2. To assess the efficacy of MK-1167 as adjunctive therapy to acetylcholinesterase inhibitors on the ADCS-ADL Total Score as compared with placebo at Week 24.
3. To assess the efficacy of MK-1167 as adjunctive therapy on the ADAS-Cog11 Total Score compared with placebo at Week 12.
4. To assess the efficacy of MK-1167 as adjunctive therapy on the ADCS-CGIC Overall Score compared with placebo at Week 12.
5. To assess the efficacy of MK-1167 as adjunctive therapy on the ADCS-ADL Total Score as compared with placebo at Week 12.

Conditions and MedDRA coding

Alzheimer’s disease dementia

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has mild to moderate Alzheimer’s Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer’s Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease
2. Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)
3. Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia
4. Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status

Exclusion criteria 9

1. Has a known history of stroke or cerebrovascular disease
2. Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically
3. Has structural brain disease
4. Has a history of seizures or epilepsy
5. Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)
6. Has major medical illness or unstable medical condition
7. Has a history of malignancy
8. Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)
9. Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24
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 5

1. Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24
2. Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24
3. Change From Baseline in the ADAS-Cog11 Total Score at Week 12
4. ADCS-CGIC Overall Score at Week 12
5. Change From Baseline in the ADCS-ADL Total Score at Week 12

Investigational products

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

Test 3

Placebo 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

Yi Mo

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Yi Mo

Third parties 7

Locations

3 EU/EEA countries · 16 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 32 files

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

Application history

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