Prazosin for Agitation in Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen ByHoward Feldman

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alzheimer's Disease Cooperative Study (ADCS)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The study evaluates the effects of Prazosin on agitation in adults with Alzheimer's disease. Two thirds of the participants will participate in the medication portion, while one third will participate in the placebo portion

Eligibility Criteria

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Treatment (Prazosin)Active Control1 Intervention

Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period. Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3 1 mg QAM and 1 mg QHS for days 4 to 7 1. mg QAM and 2 mg QHS for days 8 to 10 2. mg QAM and 2 mg QHS for days 11 to 14 Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29, Dose increases will be allowed only during the fixed and flexible dosing periods.

Group II: Placebo oral capsulePlacebo Group1 Intervention

Placebo medication will be administered in a titration schedule mimicking the active comparator treatment.