RECRUITING

A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Researchers want to learn if giving MK-1167 (the study medicine) along with acetylcholinesterase inhibitor (AChEI) therapy can improve symptoms of Alzheimer's disease dementia (AD dementia), such as memory and mental activity. AD dementia is the most common type of dementia. AChEI therapy is the standard treatment for AD dementia. The goals of this study are to learn: * If at least one dose level (amount) of MK-1167 works to improve a person's memory and thinking compared to a placebo * About the safety of MK-1167 and if people tolerate it

Official Title

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

Quick Facts

Study Start:2024-12-31
Study Completion:2027-07-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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
  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

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Aqualane Clinical Research ( Site 0116)
Naples, Florida, 34105
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-31
Study Completion Date2027-07-20

Study Record Updates

Study Start Date2024-12-31
Study Completion Date2027-07-20

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease
  • Dementia