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Treatment (Prazosin) for Alzheimer's Disease

Phase 2
Waitlist Available
Led By Howard Feldman
Research Sponsored by Alzheimer's Disease Cooperative Study (ADCS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

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

Eligible Conditions
  • Alzheimer's Disease
  • Disruptive Behavior

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A)
Secondary outcome measures
ADCS-ADL-Severe
Caregiver Distress on NPI/NPI-NH
Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH)
+3 more
Other outcome measures
Cohen Mansfield Agitation Inventory (CMAI).
Five-domain NPI/NPI-NH Subset Score
Sleep Continuity

Trial Design

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.

Find a Location

Who is running the clinical trial?

Alzheimer's Disease Cooperative Study (ADCS)Lead Sponsor
24 Previous Clinical Trials
6,396 Total Patients Enrolled
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
224,770 Total Patients Enrolled
Alzheimer's AssociationOTHER
95 Previous Clinical Trials
42,265 Total Patients Enrolled
~5 spots leftby Sep 2025
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