Skip to main content
OpenTrials
Completed

NCT Number: NCT06285240

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, Hallandale Beach ( Site 0001), Hallandale, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-1167

Drug

1 mg and 5 mg oral capsules

Donepezil

Drug

10 mg oral tablets

Placebo

Drug

MK-1167 matching placebo administered oral capsules

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. 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

    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.

  15. 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

    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.

  16. 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

    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.

  17. 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

    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.

  18. 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

    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.

  19. 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

    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.

  20. 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

    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.

  21. 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

    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.

  22. 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

    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.

  23. 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

    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.

  24. 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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.