Clinical trial NCT06721156: A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Dementia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 350
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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
* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)
* Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases

Primary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24
timeFrame: Baseline and up to approximately 24 weeks
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 28 weeks
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 24 weeks
Secondary outcomes:
measure: Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24
timeFrame: Baseline and up to approximately 24 weeks
measure: Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24
timeFrame: Baseline and up to approximately 24 weeks
measure: Change From Baseline in the ADAS-Cog11 Total Score at Week 12
timeFrame: Baseline and up to approximately 12 weeks
measure: ADCS-CGIC Overall Score at Week 12
timeFrame: Baseline and up to approximately 12 weeks
measure: Change From Baseline in the ADCS-ADL Total Score at Week 12
timeFrame: Baseline and up to approximately 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute ( Site 0110)
state: Arizona
city: Irvine
country: United States
facility: Irvine Clinical Research ( Site 0104)
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research ( Site 0164)
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research ( Site 0118)
state: California
city: Atlantis
country: United States
facility: JEM Research Institute / Headlands Research Network ( Site 0108)
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research-Neurology ( Site 0150)
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida ( Site 0152)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 0128)
state: Florida
city: Lady Lake
country: United States
facility: K2 Medical Research THE VILLAGES ( Site 0166)
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research ( Site 0103)
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute ( Site 0114)
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research ( Site 0116)
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando ( Site 0169)
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research ( Site 0151)
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research Tampa LLC ( Site 0165)
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center ( Site 0197)
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC ( Site 0134)
state: Georgia
city: Marrero
country: United States
facility: Tandem Clinical Research ( Site 0101)
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc. ( Site 0167)
state: Maryland
city: Farmington Hills
country: United States
facility: Quest Research Institute ( Site 0173)
state: Michigan
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse ( Site 0125)
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research ( Site 0191)
state: New York
city: Matthews
country: United States
facility: Flourish Research - Charlotte ( Site 0106)
state: North Carolina
city: Raleigh
country: United States
facility: Velocity Clinical Research - Raleigh ( Site 0123)
state: North Carolina
city: Portland
country: United States
facility: Summit Research Network ( Site 0111)
state: Oregon
city: Dallas
country: United States
facility: Kerwin Medical Center ( Site 0159)
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center ( Site 0105)
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center ( Site 0102)
state: Washington
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials ( Site 0001)
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Memory Clinic ( Site 0004)
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program ( Site 0006)
state: Ontario
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)
state: Monza E Brianza
city: Brescia
country: Italy
facility: Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)
city: Milano
country: Italy
facility: Ospedale San Raffaele. ( Site 0901)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905)
city: Kawasaki
country: Japan
facility: Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510)
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kawasaki Saiwai Clinic ( Site 1501)
state: Kanagawa
city: Hirakata
country: Japan
facility: Hatsuta Neurology Clinic ( Site 1507)
state: Osaka
city: Toyonaka
country: Japan
facility: Nagomi Clinic ( Site 1506)
state: Osaka
city: Kasukabe
country: Japan
facility: Takesato Hospital ( Site 1522)
state: Saitama
city: Anan
country: Japan
facility: Iwaki Clinic ( Site 1518)
state: Tokushima
city: Chofu
country: Japan
facility: Enomoto Internal Medicine Clinic(Chofu) ( Site 1503)
state: Tokyo
city: Itabashi
country: Japan
facility: Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515)
state: Tokyo
city: Mitaka
country: Japan
facility: Nozomi Memory Clinic ( Site 1504)
state: Tokyo
city: Tokushima
country: Japan
facility: Itsuki Hospital ( Site 1502)
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital ( Site 1601)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1604)
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital ( Site 1605)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1603)
city: Den Bosch
country: Netherlands
facility: Brain Research Center Den Bosch B.V. ( Site 1002)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Brain Research Center. ( Site 1001)
state: Noord-Holland
city: Zwolle
country: Netherlands
facility: Brain Research Center Zwolle ( Site 1003)
state: Overijssel
city: Algorta
country: Spain
facility: Centro de Atención Especializada Oroitu ( Site 1211)
state: Bizkaia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau ( Site 1204)
state: Cataluna
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1208)
state: Madrid, Comunidad De
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe ( Site 1202)
state: Valencia
city: Barcelona
country: Spain
facility: Fundació ACE ( Site 1206)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron ( Site 1203)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena ( Site 1210)
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health - Birmingham ( Site 1406)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: