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MK-1167 for Alzheimer's Disease

Phase 1

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

"This trial aims to test if MK-1167 is safe and effective for patients with Alzheimer's Disease who are already taking Donepezil."

Who is the study for?

This trial is for people with Alzheimer's Disease who have been experiencing cognitive and functional decline for at least a year. They must be diagnosed with probable AD, have a caregiver willing to assist, and have been on a stable dose of Donepezil (10 mg daily) for two months before the study.Check my eligibility

What is being tested?

The trial is testing MK-1167's effectiveness and safety in individuals already taking Donepezil for Alzheimer's. Participants will either receive MK-1167 or a placebo to see if there is an improvement in their condition.See study design

What are the potential side effects?

While specific side effects are not listed here, common side effects from drugs like MK-1167 may include nausea, diarrhea, insomnia, muscle cramps, fatigue, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants discontinuing study treatment due to an AE

Number of participants experiencing an Adverse Event (AE)

Secondary outcome measures

Apparent Terminal Half-Life (t½) of MK-1167

Apparent Volume of Distribution (Vz/F) of MK-1167

Area Under the Plasma Concentration-Time Curve from Dosing to 24 Hours Postdose (AUC0-24) of MK-1167

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-1167Experimental Treatment2 Interventions

Participants receive 6 mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3 mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also receive 10 mg oral Donepezil on Days -3 to 21.

Group II: PlaceboPlacebo Group3 Interventions

Participants receive placebo to MK-1167 oral QD from Days 1 to 21. Participants also receive 10 mg oral Donepezil QD on Days -3 to 21

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donepezil

2011

Completed Phase 4

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,061,126 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,064,388 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for participation in this medical study, specifically with respect to individuals older than 25 years?

"To be eligible for this research study, individuals must fall within the age bracket of 50 to 90 years. Notably, there are no less than 14 trials tailored for patients below 18 and a substantial number of 523 studies focused on those above the age of consent."

Answered by AI

What is the current number of subjects participating in this medical research study?

"The details on clinicaltrials.gov confirm that this medical investigation is actively seeking candidates. Initially listed on March 28, 2024, the trial's most recent update was on April 2, 2024. A total of 16 participants are sought from three distinct sites."

Answered by AI

Which specific criteria must individuals meet in order to qualify as potential participants for this research study?

"The research aims to recruit 16 individuals aged between 50 and 90 who have been diagnosed with Alzheimer's disease. Eligible participants must demonstrate a history of cognitive and functional decline that has developed gradually over the course of at least one year before the screening process. This decline should either be confirmed by an individual familiar with the patient or documented in their medical records. Moreover, candidates need to meet the diagnostic criteria for probable Alzheimer's disease according to guidelines established by both NINCDS-ADRDA. Additionally, they are required to have a dependable caregiver who maintains close contact with them at least three days per week for a minimum of six waking"

Answered by AI

What are the main goals that this investigation aims to achieve?

"During the study period lasting approximately 3 weeks, the primary goal is to track and document any Adverse Events (AE) experienced by participants. Secondary measures will include assessing Oral Clearance (CL/F) of MK-1167 from Plasma, denoting how swiftly MK-6552 is eliminated from plasma; Plasma Concentration at 24 hours postdose (C24), reflecting levels of MK-1167 in plasma after a specified timeframe; and Time to Reach Maximum Plasma Concentration (Tmax) of MK-1167, indicating how quickly maximum drug concentration in plasma is achieved following dosing."

Answered by AI

Are there still available openings for new participants in this research study?

"Indeed, the details on clinicaltrials.gov specify that patient recruitment is ongoing for this investigation. This trial was initially uploaded on March 28th, 2024 and last revised on April 2nd, 2024. The aim is to enroll a total of 16 participants from three distinct sites."

Answered by AI