Donepezil for Alzheimer's Disease (DDI Trial)

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

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 day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose

Summary

This trial is testing a new drug, MK-1942, together with an existing Alzheimer's medication, donepezil. It focuses on patients with mild-to-moderate Alzheimer's who are already taking donepezil. The study aims to see if this combination is safe and if it causes any new or more severe side effects. Researchers will also check how the body processes both drugs when taken together. Donepezil is a well-established treatment for Alzheimer's disease, used to improve cognition and global function in patients with mild to severe stages of the disease.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change From Baseline in Heart Rate (HR)

Change From Baseline in Systolic Blood Pressure (SBP)

Mean Change From Baseline in Diastolic Blood Pressure (DBP)

+8 more

Secondary study objectives

AUC From Dosing to 24 Hours Postdose (AUC0-24) of MK-1942

AUC0-24 of Donepezil

Apparent Clearance at Steady-state (CLss/F) of MK-1942

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DonepezilExperimental Treatment2 Interventions

Participants receive Dose Level 1: 8-mg MK-1942 twice daily (BID) x 7 days (7D), Day 1 to Day 7; Dose Level 2: 15-mg MK-1942 BID x 7D, Day 8 to Day 14; Dose Level 3: 30-mg MK-1942 BID x 7D, Day 15 to Day 21; Dose Level 4: ≤50-mg MK-1942 BID x 7D (Provisional Dose Level), Day 22 to Day 28 All participants to receive Donepezil once daily.

Group II: PlaceboPlacebo Group2 Interventions

Placebo to MK-1942 BID x 21 \[28\] D All participants to receive Donepezil once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-1942

2021

Completed Phase 1

~30

Donepezil

2011