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
Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Banner Alzheimer's Institute ( Site 0110)
RECRUITING
Phoenix
California
Irvine Clinical Research ( Site 0104)
RECRUITING
Irvine
Anderson Clinical Research ( Site 0164)
RECRUITING
Redlands
California Neuroscience Research ( Site 0118)
RECRUITING
Sherman Oaks
Florida
JEM Research Institute / Headlands Research Network ( Site 0108)
RECRUITING
Atlantis
Brain Matters Research-Neurology ( Site 0150)
RECRUITING
Delray Beach
Neuropsychiatric Research Center of Southwest Florida ( Site 0152)
RECRUITING
Fort Myers
Indago Research & Health Center, Inc ( Site 0128)
RECRUITING
Hialeah
K2 Medical Research THE VILLAGES ( Site 0166)
RECRUITING
Lady Lake
K2 Medical Research ( Site 0103)
RECRUITING
Maitland
Premier Clinical Research Institute ( Site 0114)
RECRUITING
Miami
Aqualane Clinical Research ( Site 0116)
RECRUITING
Naples
Headlands Research Orlando ( Site 0169)
RECRUITING
Orlando
Brain Matters Research ( Site 0151)
RECRUITING
Stuart
K2 Medical Research Tampa LLC ( Site 0165)
RECRUITING
Tampa
Georgia
Columbus Memory Center ( Site 0197)
COMPLETED
Columbus
CenExel iResearch, LLC ( Site 0134)
RECRUITING
Savannah
Louisiana
Tandem Clinical Research ( Site 0101)
RECRUITING
Marrero
Maryland
Pharmasite Research, Inc. ( Site 0167)
RECRUITING
Baltimore
Michigan
Quest Research Institute ( Site 0173)
RECRUITING
Farmington Hills
North Carolina
Flourish Research - Charlotte ( Site 0106)
RECRUITING
Matthews
Velocity Clinical Research - Raleigh ( Site 0123)
RECRUITING
Raleigh
New York
Velocity Clinical Research, Syracuse ( Site 0125)
RECRUITING
East Syracuse
Mid Hudson Medical Research ( Site 0191)
RECRUITING
New Windsor
Oregon
Summit Research Network ( Site 0111)
RECRUITING
Portland
Texas
Kerwin Medical Center ( Site 0159)
RECRUITING
Dallas
Grayline Research Center ( Site 0105)
RECRUITING
Wichita Falls
Washington
Northwest Clinical Research Center ( Site 0102)
RECRUITING
Bellevue
Other Locations
Argentina
Hospital Italiano de Buenos Aires ( Site 0209)
RECRUITING
Buenos Aires
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
RECRUITING
Buenos Aires
Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
RECRUITING
Buenos Aires
Instituto Kremer ( Site 0202)
RECRUITING
Córdoba
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0207)
RECRUITING
Mar Del Plata
Canada
Okanagan Clinical Trials ( Site 0001)
RECRUITING
Kelowna
Ottawa Memory Clinic ( Site 0004)
RECRUITING
Ottawa
Toronto Memory Program ( Site 0006)
RECRUITING
Toronto
Italy
Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)
RECRUITING
Brescia
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 0903)
RECRUITING
Milan
Ospedale San Raffaele. ( Site 0901)
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)
RECRUITING
Monza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905)
RECRUITING
Roma
Japan
Iwaki Clinic ( Site 1518)
RECRUITING
Anan
Enomoto Internal Medicine Clinic(Chofu) ( Site 1503)
RECRUITING
Chōfu
Hatsuta Neurology Clinic ( Site 1507)
RECRUITING
Hirakata
Takesato Hospital ( Site 1522)
RECRUITING
Kasukabe
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510)
RECRUITING
Kawasaki
Kawasaki Saiwai Clinic ( Site 1501)
RECRUITING
Kawasaki
Nozomi Memory Clinic ( Site 1504)
RECRUITING
Mitaka
Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515)
RECRUITING
Tabashi City
Itsuki Hospital ( Site 1502)
RECRUITING
Tokushima
Nagomi Clinic ( Site 1506)
RECRUITING
Toyonaka
Netherlands
Brain Research Center Den Bosch B.V. ( Site 1002)
RECRUITING
's-hertogenbosch
Brain Research Center. ( Site 1001)
RECRUITING
Amsterdam
Brain Research Center Zwolle ( Site 1003)
RECRUITING
Zwolle
Republic of Korea
Inha University Hospital ( Site 1601)
RECRUITING
Incheon
Asan Medical Center ( Site 1603)
RECRUITING
Seoul
Hanyang University Seoul Hospital ( Site 1605)
RECRUITING
Seoul
Seoul National University Hospital ( Site 1604)
RECRUITING
Seoul
Spain
Centro de Atención Especializada Oroitu ( Site 1211)
RECRUITING
Algorta
Fundació ACE ( Site 1206)
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau ( Site 1204)
RECRUITING
Barcelona
Hospital Universitari Vall D Hebron ( Site 1203)
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre ( Site 1208)
RECRUITING
Madrid
Hospital Universitario Virgen de la Macarena ( Site 1210)
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe ( Site 1202)
RECRUITING
Valencia
United Kingdom
Brain Sciences Scotland Life Sciences-Aberdeen ( Site 1402)
RECRUITING
Aberdeen
Remind UK ( Site 1404)
RECRUITING
Bath
Re:Cognition Health - Birmingham ( Site 1406)
RECRUITING
Birmingham
Windsor Research Unit ( Site 1403)
RECRUITING
Cambridge
Scottish Brain Sciences ( Site 1401)
RECRUITING
Edinburgh
Campus for Ageing and Vitality ( Site 1408)
RECRUITING
Newcastle Upon Tyne
Moorgreen Hospital ( Site 1409)
RECRUITING
Southampton
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2027-01-12
Participants
Target number of participants: 350
Treatments
Experimental: MK-1167 3 mg
Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.
Experimental: MK-1167 1 mg
Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.
Experimental: MK-1167 0.3 mg
Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.
Placebo_comparator: Placebo
Participants take placebo QD for up to approximately 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC