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

Last updated: February 18, 2026
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
2024-515539-31-00
  • 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:
December 31, 2026

Connect with a study center

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0207)

    Mar del Plata 3430863, Buenos Aires 3435907 B7600FZN
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0209)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1199ABD
    Argentina

    Active - Recruiting

  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1012AAR
    Argentina

    Active - Recruiting

  • Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1427CCP
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0209)

    Ciudad Autonoma de Buenos Aires, Caba C1199ABD
    Argentina

    Active - Recruiting

  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)

    Ciudad Autonoma de Buenos Aires, Caba C1012AAR
    Argentina

    Active - Recruiting

  • Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)

    Ciudad Autonoma de Buenos Aires, Caba C1427CCP
    Argentina

    Site Not Available

  • Organizacion Medica de Investigacion - OMI S.A. ( Site 0204)

    Buenos Aires 3435910, C1015ABO
    Argentina

    Active - Recruiting

  • Instituto Kremer ( Site 0202)

    Cordoba, X5004AOA
    Argentina

    Site Not Available

  • Instituto Kremer ( Site 0202)

    Córdoba 3860259, X5004AOA
    Argentina

    Active - Recruiting

  • Okanagan Clinical Trials ( Site 0001)

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • Okanagan Clinical Trials ( Site 0001)

    Kelowna 5990579, British Columbia 5909050 V1Y 1Z9
    Canada

    Active - Recruiting

  • Ottawa Memory Clinic ( Site 0004)

    Ottawa, Ontario k1z1g3
    Canada

    Site Not Available

  • Toronto Memory Program ( Site 0006)

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Ottawa Memory Clinic ( Site 0004)

    Ottawa 6094817, Ontario 6093943 K1Z 1G3
    Canada

    Active - Recruiting

  • Toronto Memory Program ( Site 0006)

    Toronto 6167865, Ontario 6093943 M3B 2S7
    Canada

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 0903)

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 0903)

    Milan 3173435, Lombardy 3174618 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)

    Monza, Monza E Brianza 20900
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)

    Monza 3172629, Monza E Brianza 20900
    Italy

    Active - Recruiting

  • Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)

    Brescia, 25125
    Italy

    Site Not Available

  • Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)

    Brescia 3181554, 25125
    Italy

    Active - Recruiting

  • Ospedale San Raffaele. ( Site 0901)

    Milan 6951411, 20132
    Italy

    Active - Recruiting

  • Ospedale San Raffaele. ( Site 0901)

    Milano, 20132
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905)

    Roma, 00136
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905)

    Roma 8957247, 00168
    Italy

    Active - Recruiting

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

    Kawasaki, Kanagawa 210-0852
    Japan

    Site Not Available

  • Kawasaki Saiwai Clinic ( Site 1501)

    Kawasaki, Kanagawa 212-0016
    Japan

    Active - Recruiting

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

    Kawasaki 1859642, Kanagawa 1860291 210-0852
    Japan

    Active - Recruiting

  • Kawasaki Saiwai Clinic ( Site 1501)

    Kawasaki 1859642, Kanagawa 1860291 212-0016
    Japan

    Active - Recruiting

  • Hatsuta Neurology Clinic ( Site 1507)

    Hirakata, Osaka 573-1121
    Japan

    Site Not Available

  • Nagomi Clinic ( Site 1506)

    Toyonaka, Osaka 560-0004
    Japan

    Site Not Available

  • Hatsuta Neurology Clinic ( Site 1507)

    Hirakata 1862540, Osaka 1853904 573-1121
    Japan

    Active - Recruiting

  • Nagomi Clinic ( Site 1506)

    Toyonaka 1849837, Osaka 1853904 560-0004
    Japan

    Site Not Available

  • Takesato Hospital ( Site 1522)

    Kasukabe, Saitama 344-0036
    Japan

    Site Not Available

  • Takesato Hospital ( Site 1522)

    Kasukabe 1859884, Saitama 1853226 344-0036
    Japan

    Active - Recruiting

  • Iwaki Clinic ( Site 1518)

    Anan, Tokushima 774-0014
    Japan

    Site Not Available

  • Iwaki Clinic ( Site 1518)

    Anan 1865309, Tokushima 1850157 774-0014
    Japan

    Site Not Available

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

    Chofu, Tokyo 182-0036
    Japan

    Site Not Available

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

    Itabashi, Tokyo 173-0015
    Japan

    Site Not Available

  • Nozomi Memory Clinic ( Site 1504)

    Mitaka, Tokyo 181-0013
    Japan

    Site Not Available

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

    Chōfu 1864518, Tokyo 1850144 182-0036
    Japan

    Active - Recruiting

  • Nozomi Memory Clinic ( Site 1504)

    Mitaka 11790343, Tokyo 1850144 181-0013
    Japan

    Active - Recruiting

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

    tabashi City 1861321, Tokyo 1850144 173-0015
    Japan

    Completed

  • Itsuki Hospital ( Site 1502)

    Tokushima, 770-0852
    Japan

    Site Not Available

  • Itsuki Hospital ( Site 1502)

    Tokushima 1850158, 770-0852
    Japan

    Active - Recruiting

  • Inha University Hospital ( Site 1601)

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Asan Medical Center ( Site 1603)

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital ( Site 1605)

    Seoul, 04763
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 1604)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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

    Den Bosch, Noord-Brabant 5223 LA
    Netherlands

    Site Not Available

  • Brain Research Center. ( Site 1001)

    Amsterdam, Noord-Holland 1081 GN
    Netherlands

    Site Not Available

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

    's-Hertogenbosch 2747351, North Brabant 2749990 5223 LA
    Netherlands

    Site Not Available

  • Brain Research Center. ( Site 1001)

    Amsterdam 2759794, North Holland 2749879 1081 GN
    Netherlands

    Active - Recruiting

  • Brain Research Center Zwolle ( Site 1003)

    Zwolle, Overijssel 8025 AZ
    Netherlands

    Site Not Available

  • Brain Research Center Zwolle ( Site 1003)

    Zwolle 2743477, Overijssel 2748838 8025 AZ
    Netherlands

    Active - Recruiting

  • Inha University Hospital ( Site 1601)

    Incheon 1843564, 22332
    South Korea

    Active - Recruiting

  • Asan Medical Center ( Site 1603)

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Hanyang University Seoul Hospital ( Site 1605)

    Seoul 1835848, 04763
    South Korea

    Active - Recruiting

  • Seoul National University Hospital ( Site 1604)

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Centro de Atención Especializada Oroitu ( Site 1211)

    Algorta, Bizkaia 48993
    Spain

    Site Not Available

  • Centro de Atención Especializada Oroitu ( Site 1211)

    Algorta 3130380, Bizkaia 48993
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau ( Site 1204)

    Barcelona 3128760, Catalonia 3336901 8025
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau ( Site 1204)

    Barcelona, Cataluna 8025
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 1208)

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 1208)

    Madrid 3117735, Madrid, Comunidad de 28041
    Spain

    Completed

  • Hospital Universitari i Politecnic La Fe ( Site 1202)

    València, Valencia 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe ( Site 1202)

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Active - Recruiting

  • Fundació ACE ( Site 1206)

    Barcelona, 08034
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D Hebron ( Site 1203)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Fundació ACE ( Site 1206)

    Barcelona 3128760, 08034
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D Hebron ( Site 1203)

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Macarena ( Site 1210)

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Macarena ( Site 1210)

    Seville 2510911, 41009
    Spain

    Completed

  • Brain Sciences Scotland Life Sciences-Aberdeen ( Site 1402)

    Aberdeen, Aberdeen City AB25 2XE
    United Kingdom

    Site Not Available

  • Brain Sciences Scotland Life Sciences-Aberdeen ( Site 1402)

    Aberdeen 2657832, Aberdeen City AB25 2XE
    United Kingdom

    Active - Recruiting

  • Scottish Brain Sciences ( Site 1401)

    Edinburgh, Edinburgh, City Of EH12 5PJ
    United Kingdom

    Site Not Available

  • Scottish Brain Sciences ( Site 1401)

    Edinburgh 2650225, Edinburgh, City of EH12 5PJ
    United Kingdom

    Active - Recruiting

  • Moorgreen Hospital ( Site 1409)

    Southampton, Hampshire SO30 3JB
    United Kingdom

    Site Not Available

  • Moorgreen Hospital ( Site 1409)

    Southampton 2637487, Hampshire SO30 3JB
    United Kingdom

    Active - Recruiting

  • Remind UK ( Site 1404)

    Bath, Somerset BA1 3NG
    United Kingdom

    Site Not Available

  • Remind UK ( Site 1404)

    Bath 2656173, Somerset BA1 3NG
    United Kingdom

    Active - Recruiting

  • Re:Cognition Health - Birmingham ( Site 1406)

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham ( Site 1406)

    Birmingham 2655603, B16 8LT
    United Kingdom

    Active - Recruiting

  • Windsor Research Unit ( Site 1403)

    Cambridge 2653941, CB21 5EF
    United Kingdom

    Active - Recruiting

  • Campus for Ageing and Vitality ( Site 1408)

    Newcastle upon Tyne 2641673, NE4 5PL
    United Kingdom

    Active - Recruiting

  • Banner Alzheimer's Institute ( Site 0110)

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Banner Alzheimer's Institute ( Site 0110)

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Irvine Clinical Research ( Site 0104)

    Irvine, California 92614
    United States

    Site Not Available

  • Anderson Clinical Research ( Site 0164)

    Redlands, California 92374
    United States

    Site Not Available

  • California Neuroscience Research ( Site 0118)

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Irvine Clinical Research ( Site 0104)

    Irvine 5359777, California 5332921 92614
    United States

    Active - Recruiting

  • Anderson Clinical Research ( Site 0164)

    Redlands 5386754, California 5332921 92374
    United States

    Completed

  • California Neuroscience Research ( Site 0118)

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Active - Recruiting

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

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Brain Matters Research-Neurology ( Site 0150)

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida ( Site 0152)

    Fort Myers, Florida 33912
    United States

    Site Not Available

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

    Hialeah, Florida 33012
    United States

    Site Not Available

  • K2 Medical Research THE VILLAGES ( Site 0166)

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • K2 Medical Research ( Site 0103)

    Maitland, Florida 32750
    United States

    Site Not Available

  • Premier Clinical Research Institute ( Site 0114)

    Miami, Florida 33122
    United States

    Site Not Available

  • Aqualane Clinical Research ( Site 0116)

    Naples, Florida 34105
    United States

    Site Not Available

  • Headlands Research Orlando ( Site 0169)

    Orlando, Florida 32819
    United States

    Site Not Available

  • Brain Matters Research ( Site 0151)

    Stuart, Florida 34997
    United States

    Site Not Available

  • K2 Medical Research Tampa LLC ( Site 0165)

    Tampa, Florida 33607
    United States

    Site Not Available

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

    Atlantis 4146372, Florida 4155751 33462
    United States

    Active - Recruiting

  • Brain Matters Research-Neurology ( Site 0150)

    Delray Beach 4153132, Florida 4155751 33445
    United States

    Active - Recruiting

  • Neuropsychiatric Research Center of Southwest Florida ( Site 0152)

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Active - Recruiting

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

    Hialeah 4158476, Florida 4155751 33012
    United States

    Active - Recruiting

  • K2 Medical Research THE VILLAGES ( Site 0166)

    Lady Lake 4161118, Florida 4155751 32159
    United States

    Active - Recruiting

  • K2 Medical Research ( Site 0103)

    Maitland 4163220, Florida 4155751 32750
    United States

    Active - Recruiting

  • Premier Clinical Research Institute ( Site 0114)

    Miami 4164138, Florida 4155751 33122
    United States

    Active - Recruiting

  • Aqualane Clinical Research ( Site 0116)

    Naples 4165565, Florida 4155751 34105
    United States

    Active - Recruiting

  • Headlands Research Orlando ( Site 0169)

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Brain Matters Research ( Site 0151)

    Stuart 4174201, Florida 4155751 34997
    United States

    Active - Recruiting

  • K2 Medical Research ( Site 0165)

    Tampa 4174757, Florida 4155751 33634
    United States

    Active - Recruiting

  • K2 Medical Research Tampa LLC ( Site 0165)

    Tampa 4174757, Florida 4155751 33607
    United States

    Active - Recruiting

  • Columbus Memory Center ( Site 0197)

    Columbus, Georgia 31909
    United States

    Site Not Available

  • CenExel iResearch, LLC ( Site 0134)

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Columbus Memory Center ( Site 0197)

    Columbus 4188985, Georgia 4197000 31909
    United States

    Completed

  • CenExel iResearch, LLC ( Site 0134)

    Savannah 4221552, Georgia 4197000 31405
    United States

    Active - Recruiting

  • Tandem Clinical Research ( Site 0101)

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Tandem Clinical Research ( Site 0101)

    Marrero 4332628, Louisiana 4331987 70072
    United States

    Completed

  • Pharmasite Research, Inc. ( Site 0167)

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Pharmasite Research, Inc. ( Site 0167)

    Baltimore 4347778, Maryland 4361885 21208
    United States

    Active - Recruiting

  • Quest Research Institute ( Site 0173)

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Quest Research Institute ( Site 0173)

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • Velocity Clinical Research, Syracuse ( Site 0125)

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Mid Hudson Medical Research ( Site 0191)

    New Windsor, New York 12553
    United States

    Site Not Available

  • Velocity Clinical Research, Syracuse ( Site 0125)

    East Syracuse 5116079, New York 5128638 13057
    United States

    Completed

  • Mid Hudson Medical Research ( Site 0191)

    New Windsor 5128577, New York 5128638 12553
    United States

    Active - Recruiting

  • Flourish Research - Charlotte ( Site 0106)

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Velocity Clinical Research - Raleigh ( Site 0123)

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Flourish Research - Charlotte ( Site 0106)

    Matthews 4478334, North Carolina 4482348 28105
    United States

    Active - Recruiting

  • Velocity Clinical Research - Raleigh ( Site 0123)

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Completed

  • Summit Research Network ( Site 0111)

    Portland, Oregon 97210
    United States

    Site Not Available

  • Summit Research Network ( Site 0111)

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Kerwin Medical Center ( Site 0159)

    Dallas, Texas 75231
    United States

    Site Not Available

  • Grayline Research Center ( Site 0105)

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Kerwin Medical Center ( Site 0159)

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Grayline Research Center ( Site 0105)

    Wichita Falls 4741752, Texas 4736286 76309
    United States

    Active - Recruiting

  • Northwest Clinical Research Center ( Site 0102)

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Northwest Clinical Research Center ( Site 0102)

    Bellevue 5786882, Washington 5815135 98007
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.