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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-28

Study Completion Date

2024-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Panel A: MK-1167 + Donepezil 10mg QD

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.

Group Type EXPERIMENTAL

MK-1167

Intervention Type DRUG

1 mg and 5 mg oral capsules

Donepezil

Intervention Type DRUG

10 mg oral tablets

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

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.

Group Type PLACEBO_COMPARATOR

Donepezil

Intervention Type DRUG

10 mg oral tablets

Placebo

Intervention Type DRUG

MK-1167 matching placebo administered oral capsules

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

Participants receive 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.

Group Type EXPERIMENTAL

MK-1167

Intervention Type DRUG

1 mg and 5 mg oral capsules

Donepezil

Intervention Type DRUG

10 mg oral tablets

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

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.

Group Type PLACEBO_COMPARATOR

Donepezil

Intervention Type DRUG

10 mg oral tablets

Placebo

Intervention Type DRUG

MK-1167 matching placebo administered oral capsules

Interventions

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MK-1167

1 mg and 5 mg oral capsules

Intervention Type DRUG

Donepezil

10 mg oral tablets

Intervention Type DRUG

Placebo

MK-1167 matching placebo administered oral capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No