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MK-1167 for Alzheimer's Disease

Phase 1

Waitlist Available

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 at designated time points up to day 51

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.

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.

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 ~ at designated time points up to day 51

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at designated time points up to day 51

This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated time points up to day 51 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants discontinuing study treatment due to an AE

Number of participants experiencing an Adverse Event (AE)

Secondary study objectives

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

4Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-1167 Panel BExperimental Treatment2 Interventions

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

Group II: MK-1167 Panel AExperimental Treatment2 Interventions

Participants receive 6 mg MK-1167 oral loading doses 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 III: Placebo Panel APlacebo Group2 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

Group IV: Placebo Panel BPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donepezil

2011

Completed Phase 4

~2070