Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)

NCT06285240 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 1167-007MK-1167-007
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Study Arms (4)

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.

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.

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.

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.

Drug: Donepezil; Drug: Placebo

Interventions

MK-1167 DRUG

1 mg and 5 mg oral capsules

Panel A: MK-1167 + Donepezil 10mg QD; Panel B: MK-1167 6mg QD + Donepezil 10mg QD

Donepezil DRUG

10 mg oral tablets

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

Placebo DRUG

MK-1167 matching placebo administered oral capsules

Panel A: Placebo to MK-1167 + Donepezil 10mg QD; Panel B: Placebo to MK-1167 + Donepezil 10mg QD

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Velocity Clinical Research, Hallandale Beach ( Site 0001)

Hallandale, Florida, 33009, United States

Location

CenExel iResearch, LLC ( Site 0003)

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC ( Site 0004)

Savannah, Georgia, 31405, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 28, 2024
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3)