Alzheimer's DiseasePhase 1NCT06285240
Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)
A Phase 1 study testing MK-1167 and Donepezil in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial summary
The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MK-1167 and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Mar 2024to 23 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reports a history of cognitive and functional decline with gradual onset and slow progression for at least 1 year before Screening, that is either corroborated by an informant who knows the subject well or is documented in medical records
- Meets the criteria for a diagnosis of probable Alzheimer's disease (AD) based on the National Institute of Neurological and Communicative Disorders - Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD
- Is receiving donepezil 10 mg daily for symptomatic treatment of cognitive impairment associated with AD. The dose level must be stable for at least 2 months prior to Screening. If receiving donepezil via a transdermal system (ie, patch), it should be a 10-mg/day dose and should switch prescription to a 10-mg oral daily dose, before enrollment
- Has a reliable and competent trial partner/caregiver who has a close relationship with the participant, has face-to-face contact at least 3 days a week for a minimum of 6 waking hours a week, and is willing to accompany the participant, if desired, to study visits
Who cannot join
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases that are not under medical control over the past 2 months.
- Has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5 criteria, or has a history of clinically significant psychiatric disorder in the last 5 years. Generalized anxiety disorder, and/or insomnia under good control for ≥ 2 months on stable medical therapy may not be exclusionary.
- History of cancer (malignancy). Participants with adequately treated disease deemed as "cured," or who, in the opinion of the study investigator, are highly unlikely to sustain a recurrence for the duration of the study, may be enrolled at the discretion of the investigator and Sponsor.
- History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
- Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit. There may be certain protocol-specified medications that are permitted.
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- The participant is a smoker and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening.
- Consumes greater than 3 servings of alcoholic beverages per day. Participants who consume 4 servings of alcoholic beverages per day may be enrolled at the discretion of the investigator.
- The participant is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CenExel iResearch, LLC ( Site 0003)
Decatur, Georgia, 30030
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, 33009
CenExel iResearch, LLC ( Site 0004)
Savannah, Georgia, 31405
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 Administered to Patients With Alzheimer's Disease Receiving Stable Donepezil Treatment
The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment.
- Conditions
- Alzheimer's Disease
- Being tested
- MK-1167, Donepezil, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1167Drug
1 mg and 5 mg oral capsules
DonepezilDrug
10 mg oral tablets
PlaceboDrug
MK-1167 matching placebo administered oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Panel A: MK-1167 + Donepezil 10mg QD | Experimental | Participants receive 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also receive 10mg oral Donepezil on Days -3 to 21. Receives: Drug: MK-1167; Drug: Donepezil |
| Panel A: Placebo to MK-1167 + Donepezil 10mg QD | Placebo comparator | Participants receive dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also receive 10mg oral Donepezil QD on Days -3 to 21. Receives: Drug: Donepezil; Drug: Placebo |
| Panel B: MK-1167 6mg QD + Donepezil 10mg QD | Experimental | Participants receive 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31. Receives: Drug: MK-1167; Drug: Donepezil |
| Panel B: Placebo to MK-1167 + Donepezil 10mg QD | Placebo comparator | Participants receive dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also receive 10mg oral Donepezil QD on Days -3 to 31. Receives: Drug: Donepezil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
Measured: Up to approximately 7 weeks
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE were reported.
Measured: Up to approximately 4 weeks
Secondary outcomes (24)
Panel A: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) After Administration of 6mg of MK-1167
AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Blood samples were collected at pre-specified intervals for the determination of AUC0-24. Per protocol, AUC0-24 was based on noncompartmental analysis, and a geometric mean AUC0-24 value was presented for Panel A participants after administration of 6mg of MK-1167.
Measured: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: AUC0-24 After Administration of 3mg of MK-1167
AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Blood samples were collected at pre-specified intervals for the determination of AUC0-24. Per protocol, AUC0-24 was based on noncompartmental analysis, and a geometric mean AUC 0-24 value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: AUC0-24 After Administration of 6mg of MK-1167
AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Blood samples were collected at pre-specified intervals for the determination of AUC0-24. Per protocol, AUC0-24 was based on noncompartmental analysis, and a geometric mean AUC0-24 value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Maximum Plasma Concentration (Cmax) After Administration of 6mg of MK-1167
Cmax was defined as the maximum serum concentration of MK-1167 reached. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, Cmax was based on noncompartmental analysis, and a geometric mean Cmax value was presented for Panel A participants after administration of 6mg of MK-1167.
Measured: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Cmax After Administration of 3mg of MK-1167
Cmax was defined as the maximum serum concentration of MK-1167 reached. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, Cmax was based on noncompartmental analysis, and a geometric mean Cmax value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Cmax After Administration of 6mg of MK-1167
Cmax was defined as the maximum serum concentration of MK-1167 reached. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, Cmax was based on noncompartmental analysis, and a geometric mean Cmax value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Plasma Concentration at 24 Hours (C24) After Administration of 6mg of MK-1167
C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Per protocol, C24 was based on noncompartmental analysis, and a geometric mean C24 value was presented for Panel A participants after administration of 6mg of MK-1167.
Measured: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: C24 After Administration of 3mg of MK-1167
C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Per protocol, C24 was based on noncompartmental analysis, and a geometric mean C24 value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: C24 After Administration of 6mg of MK-1167
C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Per protocol, C24 was based on noncompartmental analysis, and a geometric mean C24 value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Time to Maximum Plasma Concentration (Tmax) After Administration of 6mg of MK-1167
Tmax was defined as time to the maximum concentration of MK-1167 reached. Blood samples were collected at pre-specified intervals for the determination of Tmax. Per protocol, Tmax was based on noncompartmental analysis, and a median Tmax value was presented for Panel A participants after administration of 6mg of MK-1167.
Measured: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Tmax After Administration of 3mg of MK-1167
Tmax was defined as time to the maximum concentration of MK-1167 reached. Blood samples were collected at pre-specified intervals for the determination of Tmax. Per protocol, Tmax was based on noncompartmental analysis, and a median Tmax value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Tmax After Administration of 6mg of MK-1167
Tmax was defined as time to the maximum concentration of MK-1167 reached. Blood samples were collected at pre-specified intervals for the determination of Tmax. Per protocol, Tmax was based on noncompartmental analysis, and a median Tmax value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Apparent Clearance (CL/F) After Administration of 3mg of MK-1167
CL/F is the rate at which the MK-1167 is completely removed from plasma. Blood samples were collected at pre-specified intervals for the determination of CL/F. Per protocol, CL/F was based on noncompartmental analysis, and a geometric mean CL/F value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: CL/F After Administration of 6mg of MK-1167
CL/F is the rate at which the MK-1167 is completely removed from plasma. Blood samples were collected at pre-specified intervals for the determination of CL/F. Per protocol, CL/F was based on noncompartmental analysis, and a geometric mean CL/F value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel A: Apparent Terminal Half-Life (t1/2) After Administration of 3mg of MK-1167
t1/2 is defined as the time required to divide plasma concentration of MK-1167 by half after reaching pseudo-equilibrium. Blood samples were collected at pre-specified intervals for the determination of t1/2. Per protocol, t1/2 was based on noncompartmental analysis, and a geometric mean t1/2 value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: t1/2 After Administration of 6mg of MK-1167
t1/2 was defined as the time required to divide plasma concentration of MK-1167 by half after reaching pseudo-equilibrium. Blood samples were collected at pre-specified timepoints for the determination of t1/2. Per protocol, t1/2 was based on noncompartmental analysis, and a geometric mean t1/2 value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel A: Apparent Volume of Distribution (Vz/F) After Administration of 3mg of MK-1167
Vz/F was the apparent volume of distribution of MK-1167. Blood samples were collected at pre-specified intervals for the determination of Vz/F. Per protocol, Vz/F was based on noncompartmental analysis, and a geometric mean Vz/F value was presented for Panel A participants after administration of 3mg of MK-1167.
Measured: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: Vz/F After Administration of 6mg of MK-1167
Vz/F was the apparent volume of distribution of MK-1167. Blood samples were collected at pre-specified intervals for the determination of Vz/F. Per protocol, Vz/F was based on noncompartmental analysis, and a geometric mean Vz/F value was presented for Panel B participants after administration of 6mg of MK-1167.
Measured: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: Day 23 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Blood samples were collected at pre-specified timepoints to determine AUC0-24 on Days 1 and 23. AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Accumulation ratio of MK-1167 Day 23 to Day 1 was calculated as Day 23 AUC0-24/Day 1 AUC0-24.
Measured: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 31 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Blood samples were collected at pre-specified timepoints to determine AUC0-24 on Days 1 and 31. AUC0-24 was defined as the area under the concentration-time curve of MK-1167 from time zero to 24 hours. Accumulation ratio of MK-1167 Day 31 to Day 1 was calculated as Day 31 AUC0-24/Day 1 AUC0-24.
Measured: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 23 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Blood samples were collected at pre-specified timepoints to determine Cmax on Days 1 and 23. Cmax was defined as the maximum serum concentration of MK-1167 reached. Accumulation ratio of MK-1167 Day 23 to Day 1 was calculated as Day 23 Cmax/Day 1 Cmax.
Measured: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 31 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Blood samples were collected at pre-specified timepoints to determine Cmax on Days 1 and 31. Cmax was defined as the maximum serum concentration of MK-1167 reached. Accumulation ratio of MK-1167 Day 31 to Day 1 was calculated as Day 31 Cmax/Day 1 Cmax.
Measured: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 23 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Blood samples were collected at pre-specified timepoints to determine C24 on Days 1 and 23. C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Accumulation ratio of MK-1167 Day 23 to Day 1 was calculated as Day 23 C24/Day 1 C24.
Measured: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 31 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Blood samples were collected at pre-specified timepoints to determine C24 on Days 1 and 31. C24 was defined as the serum concentration of MK-1167 reached at 24 hours. Blood samples were collected at pre-specified timepoints for the determination of C24. Accumulation ratio of MK-1167 Day 31 to Day 1 was calculated as Day 31 C24/Day 1 C24.
Measured: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start28 Mar 2024
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Panel A participants will receive a loading dose of MK-1167 6mg or matching Placebo on Days 1 to 7 followed by once daily (QD) dosing of MK-1167 3mg or matching Placebo for 14 consecutive days (Days 8 to 21). Panel B participants will receive QD dosing of MK-1167 6mg or matching Placebo for Days 1 to 31. Panel B will be initiated following review of safety and tolerability data from Panel A.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285240
- Sponsor's protocol ID
- 1167-007
- Other IDs
- MK-1167-007
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2024
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 Administered to Patients With Alzheimer's Disease Receiving Stable Donepezil Treatment
- ClinicalTrials.gov ID
- NCT06285240
- Acronym / sponsor ID
- 1167-007
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Panel A participants will receive a loading dose of MK-1167 6mg or matching Placebo on Days 1 to 7 followed by once daily (QD) dosing of MK-1167 3mg or matching Placebo for 14 consecutive days (Days 8 to 21). Panel B participants will receive QD dosing of MK-1167 6mg or matching Placebo for Days 1 to 31. Panel B will be initiated following review of safety and tolerability data from Panel A.
| Arm | Type | Receives |
|---|---|---|
| Panel A: MK-1167 + Donepezil 10mg QD | Experimental | Drug: MK-1167, Drug: DonepezilParticipants receive 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also receive 10mg oral Donepezil on Days -3 to 21. |
| Panel A: Placebo to MK-1167 + Donepezil 10mg QD | Placebo comparator | Drug: Donepezil, Drug: PlaceboParticipants receive dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also receive 10mg oral Donepezil QD on Days -3 to 21. |
| Panel B: MK-1167 6mg QD + Donepezil 10mg QD | Experimental | Drug: MK-1167, Drug: DonepezilParticipants receive 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31. |
| Panel B: Placebo to MK-1167 + Donepezil 10mg QD | Placebo comparator | Drug: Donepezil, Drug: PlaceboParticipants receive dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also receive 10mg oral Donepezil QD on Days -3 to 31. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reports a history of cognitive and functional decline with gradual onset and slow progression for at least 1 year before Screening, that is either corroborated by an informant who knows the subject well or is documented in medical records
- Meets the criteria for a diagnosis of probable Alzheimer's disease (AD) based on the National Institute of Neurological and Communicative Disorders - Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD
- Is receiving donepezil 10 mg daily for symptomatic treatment of cognitive impairment associated with AD. The dose level must be stable for at least 2 months prior to Screening. If receiving donepezil via a transdermal system (ie, patch), it should be a 10-mg/day dose and should switch prescription to a 10-mg oral daily dose, before enrollment
- Has a reliable and competent trial partner/caregiver who has a close relationship with the participant, has face-to-face contact at least 3 days a week for a minimum of 6 waking hours a week, and is willing to accompany the participant, if desired, to study visits
Key exclusion criteria (9 listed)
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases that are not under medical control over the past 2 months.
- Has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5 criteria, or has a history of clinically significant psychiatric disorder in the last 5 years. Generalized anxiety disorder, and/or insomnia under good control for ≥ 2 months on stable medical therapy may not be exclusionary.
- History of cancer (malignancy). Participants with adequately treated disease deemed as "cured," or who, in the opinion of the study investigator, are highly unlikely to sustain a recurrence for the duration of the study, may be enrolled at the discretion of the investigator and Sponsor.
- History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
- Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-11671 mg and 5 mg oral capsules | Drug | Panel A: MK-1167 + Donepezil 10mg QD, Panel B: MK-1167 6mg QD + Donepezil 10mg QD |
| Donepezil10 mg oral tablets | Drug | Panel A: MK-1167 + Donepezil 10mg QD, Panel A: Placebo to MK-1167 + Donepezil 10mg QD, Panel B: MK-1167 6mg QD + Donepezil 10mg QD, Panel B: Placebo to MK-1167 + Donepezil 10mg QD |
| PlaceboMK-1167 matching placebo administered oral capsules | Drug | Panel A: Placebo to MK-1167 + Donepezil 10mg QD, Panel B: Placebo to MK-1167 + Donepezil 10mg QD |
Primary outcome
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 7 weeks
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to approximately 4 weeks
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE were reported.
24 secondary outcomes
Panel A: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) After Administration of 6mg of MK-1167
Time frame: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: AUC0-24 After Administration of 3mg of MK-1167
Time frame: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Time frame: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Maximum Plasma Concentration (Cmax) After Administration of 6mg of MK-1167
Time frame: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Cmax After Administration of 3mg of MK-1167
Time frame: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Cmax After Administration of 6mg of MK-1167
Time frame: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Plasma Concentration at 24 Hours (C24) After Administration of 6mg of MK-1167
Time frame: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: C24 After Administration of 3mg of MK-1167
Time frame: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: C24 After Administration of 6mg of MK-1167
Time frame: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Time to Maximum Plasma Concentration (Tmax) After Administration of 6mg of MK-1167
Time frame: Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Tmax After Administration of 3mg of MK-1167
Time frame: Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Tmax After Administration of 6mg of MK-1167
Time frame: Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: Apparent Clearance (CL/F) After Administration of 3mg of MK-1167
Time frame: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: CL/F After Administration of 6mg of MK-1167
Time frame: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel A: Apparent Terminal Half-Life (t1/2) After Administration of 3mg of MK-1167
Time frame: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: t1/2 After Administration of 6mg of MK-1167
Time frame: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel A: Apparent Volume of Distribution (Vz/F) After Administration of 3mg of MK-1167
Time frame: Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: Vz/F After Administration of 6mg of MK-1167
Time frame: Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
Panel B: Day 23 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Time frame: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 31 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Time frame: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 23 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Time frame: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 31 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Time frame: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 23 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Time frame: Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: Day 31 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Time frame: Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1167 and Donepezil in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC at 3 sites in United States.
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: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced an Adverse Event (AE) (time frame: Up to approximately 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2025.