AzTrials
AzTrials

Alzheimer DiseasePhase 2NCT06721156

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

A Phase 2 study testing MK-1167 in people with Alzheimer Disease and Dementia, run by Merck Sharp & Dohme LLC at 72 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer Disease, Dementia
What is being tested?
MK-1167
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
369 participants
Where
72 sitesin 9 countries
Study dates
16 Dec 2024to 5 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

72 sites in 9 countries.

72 sites in 9 countries

United States28 sites

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

    Atlantis, Florida, 33462

  • Pharmasite Research, Inc. ( Site 0167)

    Baltimore, Maryland, 21208

  • Northwest Clinical Research Center ( Site 0102)

    Bellevue, Washington, 98007

  • Columbus Memory Center ( Site 0197)

    Columbus, Georgia, 31909

  • Kerwin Medical Center ( Site 0159)

    Dallas, Texas, 75231

  • Brain Matters Research-Neurology ( Site 0150)

    Delray Beach, Florida, 33445

  • Velocity Clinical Research, Syracuse ( Site 0125)

    East Syracuse, New York, 13057

  • Quest Research Institute ( Site 0173)

    Farmington Hills, Michigan, 48334

  • Neuropsychiatric Research Center of Southwest Florida ( Site 0152)

    Fort Myers, Florida, 33912

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

    Hialeah, Florida, 33012

  • Irvine Clinical Research ( Site 0104)

    Irvine, California, 92614

  • K2 Medical Research THE VILLAGES ( Site 0166)

    Lady Lake, Florida, 32159

  • K2 Medical Research ( Site 0103)

    Maitland, Florida, 32750

  • Tandem Clinical Research ( Site 0101)

    Marrero, Louisiana, 70072

  • Flourish Research - Charlotte ( Site 0106)

    Matthews, North Carolina, 28105

  • Premier Clinical Research Institute ( Site 0114)

    Miami, Florida, 33122

  • Aqualane Clinical Research ( Site 0116)

    Naples, Florida, 34105

  • Mid Hudson Medical Research ( Site 0191)

    New Windsor, New York, 12553

  • Headlands Research Orlando ( Site 0169)

    Orlando, Florida, 32806

  • Banner Alzheimer's Institute ( Site 0110)

    Phoenix, Arizona, 85006

  • Summit Research Network ( Site 0111)

    Portland, Oregon, 97210

  • Velocity Clinical Research - Raleigh ( Site 0123)

    Raleigh, North Carolina, 27607

  • Anderson Clinical Research ( Site 0164)

    Redlands, California, 92374

  • CenExel iResearch, LLC ( Site 0134)

    Savannah, Georgia, 31405

  • California Neuroscience Research ( Site 0118)

    Sherman Oaks, California, 91403

  • Brain Matters Research ( Site 0151)

    Stuart, Florida, 34997

  • K2 Medical Research ( Site 0165)

    Tampa, Florida, 33634

  • Grayline Research Center ( Site 0105)

    Wichita Falls, Texas, 76309

Other trials in United States

Japan10 sites

  • Iwaki Clinic ( Site 1518)

    Anan, Tokushima, 774-0014

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

    Chōfu, Tokyo, 182-0036

  • Hatsuta Neurology Clinic ( Site 1507)

    Hirakata, Osaka, 573-1121

  • Takesato Hospital ( Site 1522)

    Kasukabe, Saitama, 344-0036

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

    Kawasaki, Kanagawa, 210-0852

  • Kawasaki Saiwai Clinic ( Site 1501)

    Kawasaki, Kanagawa, 212-0016

  • Nozomi Memory Clinic ( Site 1504)

    Mitaka, Tokyo, 181-0013

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

    tabashi City, Tokyo, 173-0015

  • Itsuki Hospital ( Site 1502)

    Tokushima, 770-0852

  • Nagomi Clinic ( Site 1506)

    Toyonaka, Osaka, 560-0004

Other trials in Japan

Spain7 sites

  • Centro de Atención Especializada Oroitu ( Site 1211)

    Algorta, Bizkaia, 48993

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

    Barcelona, Catalonia, 8025

  • Fundació ACE ( Site 1206)

    Barcelona, 08034

  • Hospital Universitari Vall D Hebron ( Site 1203)

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre ( Site 1208)

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario Virgen de la Macarena ( Site 1210)

    Seville, 41009

  • Hospital Universitari i Politecnic La Fe ( Site 1202)

    Valencia, Valencia, 46026

Other trials in Spain

United Kingdom7 sites

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

    Aberdeen, Aberdeen City, AB25 2XE

  • Remind UK ( Site 1404)

    Bath, Somerset, BA1 3NG

  • Re:Cognition Health - Birmingham ( Site 1406)

    Birmingham, B16 8LT

  • Windsor Research Unit ( Site 1403)

    Cambridge, CB21 5EF

  • Scottish Brain Sciences ( Site 1401)

    Edinburgh, Edinburgh, City of, EH12 5PJ

  • Campus for Ageing and Vitality ( Site 1408)

    Newcastle upon Tyne, NE4 5PL

  • Moorgreen Hospital ( Site 1409)

    Southampton, Hampshire, SO30 3JB

Other trials in United Kingdom

Argentina5 sites

  • Hospital Italiano de Buenos Aires ( Site 0209)

    Buenos Aires, Buenos Aires F.D., C1199ABD

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

    Buenos Aires, Buenos Aires F.D., C1427CCP

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

    Buenos Aires, C1015ABO

  • Instituto Kremer ( Site 0202)

    Córdoba, X5004AOA

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

    Mar del Plata, Buenos Aires, B7600FZN

Other trials in Argentina

Italy5 sites

  • Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)

    Brescia, 25125

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

    Milan, Lombardy, 20122

  • Ospedale San Raffaele. ( Site 0901)

    Milan, 20132

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)

    Monza, Monza E Brianza, 20900

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

    Roma, 00168

Other trials in Italy

South Korea4 sites

  • Inha University Hospital ( Site 1601)

    Incheon, 22332

  • Seoul National University Hospital ( Site 1604)

    Seoul, 03080

  • Hanyang University Seoul Hospital ( Site 1605)

    Seoul, 04763

  • Asan Medical Center ( Site 1603)

    Seoul, 05505

Other trials in South Korea

Canada3 sites

  • Okanagan Clinical Trials ( Site 0001)

    Kelowna, British Columbia, V1Y 1Z9

  • Ottawa Memory Clinic ( Site 0004)

    Ottawa, Ontario, K1Z 1G3

  • Toronto Memory Program ( Site 0006)

    Toronto, Ontario, M3B 2S7

Other trials in Canada

Netherlands3 sites

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

    's-Hertogenbosch, North Brabant, 5223 LA

  • Brain Research Center. ( Site 1001)

    Amsterdam, North Holland, 1081 GN

  • Brain Research Center Zwolle ( Site 1003)

    Zwolle, Overijssel, 8025 AZ

Other trials in Netherlands

About this study

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

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
Being tested
MK-1167, Placebo
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-1167Drug

    MK-1167 oral capsule

  • PlaceboDrug

    Placebo oral capsule

Study groups in NCT06721156
Study groupRoleWhat they receive
MK-1167 3 mgExperimentalParticipants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.
Receives: Drug: MK-1167
MK-1167 1 mgExperimentalParticipants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.
Receives: Drug: MK-1167
MK-1167 0.3 mgExperimentalParticipants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.
Receives: Drug: MK-1167
PlaceboPlacebo comparatorParticipants take placebo QD for up to approximately 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24

    The change from baseline in ADAS-Cog11 score at Week 24 is presented. ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa.

    Measured: Baseline and up to approximately 24 weeks

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 28 weeks

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 24 weeks

Secondary outcomes (5)

  1. Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24

    The overall score in ADCS-CGIC at Week 24 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study.

    Measured: Baseline and up to approximately 24 weeks

  2. Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24

    The change from baseline in ADCS-ADL score at Week 24 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity.

    Measured: Baseline and up to approximately 24 weeks

  3. Change From Baseline in the ADAS-Cog11 Total Score at Week 12

    The change from baseline in ADAS-Cog11 score at Week 12 is presented. ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa.

    Measured: Baseline and up to approximately 12 weeks

  4. ADCS-CGIC Overall Score at Week 12

    The overall score in ADCS-CGIC at Week 12 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study.

    Measured: Baseline and up to approximately 12 weeks

  5. Change From Baseline in the ADCS-ADL Total Score at Week 12

    The change from baseline in ADCS-ADL score at Week 12 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity.

    Measured: Baseline and up to approximately 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start16 Dec 2024
  3. Primary completion5 Jun 2026
  4. Study completion5 Jun 2026

Why it stopped: Termination Notes: Business reason

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06721156
Sponsor's protocol ID
1167-008
Other IDs
2024-515539-31-00, U1111-1309-3391, jRCT2031240682, MK-1167-008
Status last verified
Jun 2026
First submitted
3 Dec 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-1167 in people with Alzheimer Disease and Dementia, run by Merck Sharp & Dohme LLC at 72 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Japan, Spain, United Kingdom, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Termination Notes: Business reason). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24 (time frame: Baseline and up to approximately 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06721156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in