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

Purpose

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

Conditions

  • Alzheimer Disease
  • Dementia

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-1167 3 mg 		Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.
  • Drug: MK-1167
    MK-1167 oral capsule
Experimental
MK-1167 1 mg 		Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.
  • Drug: MK-1167
    MK-1167 oral capsule
Experimental
MK-1167 0.3 mg 		Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.
  • Drug: MK-1167
    MK-1167 oral capsule
Placebo Comparator
Placebo 		Participants take placebo QD for up to approximately 24 weeks.
  • Drug: Placebo
    Placebo oral capsule

Recruiting Locations

Banner Alzheimer's Institute ( Site 0110)
Phoenix 5308655, Arizona 5551752 85006
Contact:
Study Coordinator
602-839-6900

Irvine Clinical Research ( Site 0104)
Irvine 5359777, California 5332921 92614
Contact:
Study Coordinator
949-753-1663

California Neuroscience Research ( Site 0118)
Sherman Oaks 5395244, California 5332921 91403
Contact:
Study Coordinator
818-990-2671

JEM Research Institute / Headlands Research Network ( Site 0108)
Atlantis 4146372, Florida 4155751 33462
Contact:
Study Coordinator
561-968-2933

Brain Matters Research-Neurology ( Site 0150)
Delray Beach 4153132, Florida 4155751 33445
Contact:
Study Coordinator
561-374-8461

Neuropsychiatric Research Center of Southwest Florida ( Site 0152)
Fort Myers 4155995, Florida 4155751 33912
Contact:
Study Coordinator
561-374-8461

Indago Research & Health Center, Inc ( Site 0128)
Hialeah 4158476, Florida 4155751 33012
Contact:
Study Coordinator
305-825-6588

K2 Medical Research THE VILLAGES ( Site 0166)
Lady Lake 4161118, Florida 4155751 32159
Contact:
Study Coordinator
352-500-5252

K2 Medical Research ( Site 0103)
Maitland 4163220, Florida 4155751 32750
Contact:
Study Coordinator
407-500-5252

Premier Clinical Research Institute ( Site 0114)
Miami 4164138, Florida 4155751 33122
Contact:
Study Coordinator
305-392-0279

Aqualane Clinical Research ( Site 0116)
Naples 4165565, Florida 4155751 34105
Contact:
Study Coordinator
239-529-6780

Headlands Research Orlando ( Site 0169)
Orlando 4167147, Florida 4155751 32819
Contact:
Study Coordinator
407-705-3471

Brain Matters Research ( Site 0151)
Stuart 4174201, Florida 4155751 34997
Contact:
Study Coordinator
561-374-8461

K2 Medical Research Tampa LLC ( Site 0165)
Tampa 4174757, Florida 4155751 33607
Contact:
Study Coordinator
813-800-5252

CenExel iResearch, LLC ( Site 0134)
Savannah 4221552, Georgia 4197000 31405
Contact:
Study Coordinator
912-744-0800

Tandem Clinical Research ( Site 0101)
Marrero 4332628, Louisiana 4331987 70072
Contact:
Study Coordinator
504-934-8424

Pharmasite Research, Inc. ( Site 0167)
Baltimore 4347778, Maryland 4361885 21208
Contact:
Study Coordinator
410-602-1440

Quest Research Institute ( Site 0173)
Farmington Hills 4992523, Michigan 5001836 48334
Contact:
Study Coordinator
248-957-8940

Velocity Clinical Research, Syracuse ( Site 0125)
East Syracuse 5116079, New York 5128638 13057
Contact:
Study Coordinator
315-760-5905

Mid Hudson Medical Research ( Site 0191)
New Windsor 5128577, New York 5128638 12553
Contact:
Study Coordinator
845-561-1270

Flourish Research - Charlotte ( Site 0106)
Matthews 4478334, North Carolina 4482348 28105
Contact:
Study Coordinator
704-610-4335

Velocity Clinical Research - Raleigh ( Site 0123)
Raleigh 4487042, North Carolina 4482348 27607
Contact:
Study Coordinator
984-251-1336

Summit Research Network ( Site 0111)
Portland 5746545, Oregon 5744337 97210
Contact:
Study Coordinator
503-279-8252

Kerwin Medical Center ( Site 0159)
Dallas 4684888, Texas 4736286 75231
Contact:
Study Coordinator
972-433-9100

Grayline Research Center ( Site 0105)
Wichita Falls 4741752, Texas 4736286 76309
Contact:
Study Coordinator
940-322-1131

Northwest Clinical Research Center ( Site 0102)
Bellevue 5786882, Washington 5815135 98007
Contact:
Study Coordinator
425-453-0404

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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