2024-515539-31-00CompletedPhase 2
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 12 Nov 2024
- Start date
- 1 Apr 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Alzheimer disease
- EU CT number
- 2024-515539-31-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 79
- 16 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has a known history of stroke or cerebrovascular disease
- 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
- Has structural brain disease
- Has a history of seizures or epilepsy
- 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)
- Has major medical illness or unstable medical condition
- Has a history of malignancy
- Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases
Other
- Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)
Who the study is looking for
- 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
- Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)
- Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Completed |
| Fundació ACE, Institut Català de Neurociències Aplicades | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Oroitu S.L. | Getxo | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli | Brescia | Italy | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
| Brain Research Center Amsterdam B.V. | Amsterdam | Netherlands | Completed |
| PreCare Trial & Recruitment B.V. | Born | Netherlands | Completed |
| Brain Research Center Den Bosch B.V. | 's-Hertogenbosch | Netherlands | Completed |
| Brain Research Center Zwolle B.V. | Zwolle | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.