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

Last updated: April 21, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Treatment

Placebo

MK-1167

Clinical Study ID

NCT06721156
1167-008
U1111-1309-3391
2024-515539-31
jRCT2031240682
  • Ages 55-90
  • All Genders

Study 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

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 ofAlzheimer's Disease

  • Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)

  • Is using acetylcholinesterase inhibitors (AChEI) therapy for management of ADdementia

  • Has a designated study partner who can fulfill the requirements of this study. Thestudy partner will need to spend sufficient time with the participant to be familiarwith their overall function and behavior and be able to provide adequate informationabout the participant needed for the study including, knowledge of functional andbasic activities of daily life, work/educational history, cognitive performance,emotional/psychological state, and general health status

Exclusion

Exclusion Criteria:

  • Has a known history of stroke or cerebrovascular disease

  • Has diagnosis of a clinically relevant central nervous system (CNS) disease otherthan AD dementia or other condition that negatively impacts cognition or cognitivestatus 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, Humanimmunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirusdisease 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 continuousmedical care and nursing supervision (with protocol-specified exceptions)

  • Has liver disease, including but not limited to chronic viral hepatitis, nonviralhepatitis, cirrhosis, malignancies, autoimmune liver diseases

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 16, 2024
Estimated Completion Date:
July 20, 2027

Connect with a study center

  • Okanagan Clinical Trials ( Site 0001)

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Active - Recruiting

  • Ottawa Memory Clinic ( Site 0004)

    Ottawa, Ontario k1z1g3
    Canada

    Active - Recruiting

  • Toronto Memory Program ( Site 0006)

    Toronto, Ontario M3B 2S7
    Canada

    Active - Recruiting

  • Ospedale San Raffaele. ( Site 0901)

    Milano, 20132
    Italy

    Active - Recruiting

  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510)

    Kawasaki, Kanagawa 210-0852
    Japan

    Active - Recruiting

  • Kawasaki Saiwai Clinic ( Site 1501)

    Kawasaki, Kanagawa 212-0016
    Japan

    Active - Recruiting

  • Hatsuta Neurology Clinic ( Site 1507)

    Hirakata, Osaka 573-1121
    Japan

    Active - Recruiting

  • Nagomi Clinic ( Site 1506)

    Toyonaka, Osaka 560-0004
    Japan

    Active - Recruiting

  • Takesato Hospital ( Site 1522)

    Kasukabe, Saitama 344-0036
    Japan

    Active - Recruiting

  • Iwaki Clinic ( Site 1518)

    Anan, Tokushima 774-0014
    Japan

    Active - Recruiting

  • Enomoto Internal Medicine Clinic(Chofu) ( Site 1503)

    Chofu, Tokyo 182-0036
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515)

    Itabashi, Tokyo 173-0015
    Japan

    Active - Recruiting

  • Nozomi Memory Clinic ( Site 1504)

    Mitaka, Tokyo 181-0013
    Japan

    Active - Recruiting

  • Itsuki Hospital ( Site 1502)

    Tokushima, 770-0852
    Japan

    Active - Recruiting

  • Brain Research Center Den Bosch B.V. ( Site 1002)

    Den Bosch, Noord-Brabant 5223 LA
    Netherlands

    Active - Recruiting

  • Brain Research Center. ( Site 1001)

    Amsterdam, Noord-Holland 1081 GN
    Netherlands

    Active - Recruiting

  • Brain Research Center Zwolle ( Site 1003)

    Zwolle, Overijssel 8025 AZ
    Netherlands

    Active - Recruiting

  • Centro de Atención Especializada Oroitu ( Site 1211)

    Algorta, Bizkaia 48993
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe ( Site 1202)

    València, Valencia 46026
    Spain

    Active - Recruiting

  • Fundació ACE ( Site 1206)

    Barcelona, 08034
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Macarena ( Site 1210)

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Banner Alzheimer's Institute ( Site 0110)

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Irvine Clinical Research ( Site 0104)

    Irvine, California 92614
    United States

    Active - Recruiting

  • Anderson Clinical Research ( Site 0164)

    Redlands, California 92374
    United States

    Active - Recruiting

  • California Neuroscience Research ( Site 0118)

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • JEM Research Institute / Headlands Research Network ( Site 0108)

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Brain Matters Research-Neurology ( Site 0150)

    Delray Beach, Florida 33445
    United States

    Active - Recruiting

  • Neuropsychiatric Research Center of Southwest Florida ( Site 0152)

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Indago Research & Health Center, Inc ( Site 0128)

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • K2 Medical Research THE VILLAGES ( Site 0166)

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • K2 Medical Research ( Site 0103)

    Maitland, Florida 32750
    United States

    Active - Recruiting

  • Premier Clinical Research Institute ( Site 0114)

    Miami, Florida 33122
    United States

    Active - Recruiting

  • Aqualane Clinical Research ( Site 0116)

    Naples, Florida 34105
    United States

    Active - Recruiting

  • Headlands Research Orlando ( Site 0169)

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Brain Matters Research ( Site 0151)

    Stuart, Florida 34997
    United States

    Active - Recruiting

  • K2 Medical Research Tampa LLC ( Site 0165)

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Columbus Memory Center ( Site 0197)

    Columbus, Georgia 31909
    United States

    Active - Recruiting

  • CenExel iResearch, LLC ( Site 0134)

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Tandem Clinical Research ( Site 0101)

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Pharmasite Research, Inc. ( Site 0167)

    Baltimore, Maryland 21208
    United States

    Active - Recruiting

  • Quest Research Institute ( Site 0173)

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Velocity Clinical Research, Syracuse ( Site 0125)

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Mid Hudson Medical Research ( Site 0191)

    New Windsor, New York 12553
    United States

    Active - Recruiting

  • Flourish Research - Charlotte ( Site 0106)

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • Velocity Clinical Research - Raleigh ( Site 0123)

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Summit Research Network ( Site 0111)

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Kerwin Medical Center ( Site 0159)

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Grayline Research Center ( Site 0105)

    Wichita Falls, Texas 76309
    United States

    Active - Recruiting

  • Northwest Clinical Research Center ( Site 0102)

    Bellevue, Washington 98007
    United States

    Active - Recruiting

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