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
Key facts
- Where
- Barcelona, Getxo, Madrid, Sevilla és Valencia, SpanyolországSee the 7 sites
- Phase
- 2. fázis
Where in Spanyolország
- Fundació ACE, Institut Català de Neurociències AplicadesBarcelona, SpanyolországNo longer taking part
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Oroitu S.L.Getxo, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2024-515539-31-00
- Record updated
- 2026. május 7.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions).