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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

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 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

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,068,247 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,070,314 Total Patients Enrolled
~0 spots leftby Aug 2024