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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285240
• Other study ID #: 1167-007
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2024
• Est. completion date: August 16, 2024

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 16, 2024
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MK-1167
MK-1167 oral capsules
• Donepezil
10 mg Donepezil oral tablets
• Placebo
MK-1167 matching placebo administered orally QD

Locations

Country	Name	City	State
United States	CenExel iResearch, LLC ( Site 0003)	Decatur	Georgia
United States	Velocity Clinical Research, Hallandale Beach ( Site 0001)	Hallandale Beach	Florida
United States	CenExel iResearch, LLC ( Site 0004)	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing an Adverse Event (AE)	An AE is 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 will be reported.	Up to approximately 6 weeks
Primary	Number of participants discontinuing study treatment due to an AE	An AE is 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 discontinue study treatment due to an AE will be reported.	Up to approximately 3 weeks
Secondary	Area Under the Plasma Concentration-Time Curve from Dosing to 24 Hours Postdose (AUC0-24) of MK-1167	AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24.	Days 1, 8, and 21: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Secondary	Maximum Plasma Concentration (Cmax) of MK-1167	Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.	Days 1 and 8: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose; Days 3-7 and 10-20: predose; Day 21: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360, and 480 hours postdose
Secondary	Plasma Concentration at 24 hours postdose (C24)	Plasma concentration of MK-1167 at 24 hours (C24) will be reported.	24 hours postdose on Days 1, 8 and 21
Secondary	Time to Reach Maximum Plasma Concentration (Tmax) of MK-1167	Tmax is a measure of the time to reach the maximum concentration in plasma after the drug dose.	Days 1 and 8: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose; Days 3-7 and 10-20: predose; Day 21: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360, and 480 hours postdose
Secondary	Apparent Terminal Half-Life (t½) of MK-1167	Apparent t½ is the time required for a given drug concentration in the plasma to decrease by 50%.	Days 1 and 8: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose; Days 3-7 and 10-20: predose; Day 21: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360, and 480 hours postdose
Secondary	Oral Clearance (CL/F) of MK-1167 from Plasma	CL/F is defined as the rate at which MK-6552 is completely removed from plasma.	Days 1 and 8: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose; Days 3-7 and 10-20: predose; Day 21: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360, and 480 hours postdose
Secondary	Apparent Volume of Distribution (Vz/F) of MK-1167	Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.	Days 1 and 8: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose; Days 3-7 and 10-20: predose; Day 21: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360, and 480 hours postdose

External Links

•   Merck Clinical Trials Information