Prazosin for Agitation in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03710642|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : October 7, 2021
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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Disruptive Behavior||Drug: Prazosin Drug: Placebo oral capsule||Phase 2|
Prazosin for Disruptive Agitation in Alzheimer's Disease (PEACE-AD) is a Phase IIb multicenter, randomized, double-blind, placebo-controlled trial of 12-weeks treatment with the brain active alpha-1 adrenoreceptor (AR) antagonist prazosin for disruptive agitation in approximately 186 Alzheimer's disease (AD) residents in a long-term care (LTC) setting or living at home with full-time caregiving.
Distruptive agitation defined as having one or more of the following behaviors nearly daily during the previous week and at least intermittently for four weeks prior to screening: a) irritability, b) physically and/or verbally aggressive behavior, c) physically resistive to necessary care, d) and/or pressured motor activity (e.g., pressured pacing).
LTC is defined as assisted living or skilled nursing facility. Home dwelling participants require full-time caregiving defined as having continuous daily caregiving and a Study Partner who will assist in providing protocol specific information to the study team.
A previous single site pilot study addressing disruptive agitation in 22 predominantly LTC-residing AD participants demonstrated efficacy of prazosin on all three primary outcome measures.1 The current multicenter study is funded by the National Institute on Aging (NIA), and coordinated through the NIA-funded Alzheimer's Disease Cooperative Study (ADCS).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prazosin for Disruptive Agitation in Alzheimer's Disease (AD) (PEACE-AD)|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Active Comparator: Treatment (Prazosin)
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
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.
Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules
Placebo Comparator: Placebo oral capsule
Placebo medication will be administered in a titration schedule mimicking the active comparator treatment.
Drug: Placebo oral capsule
Placebo capsule matched to appearance of active drug.
Other Name: Placebo
- ADAS-Clinical Global Impression of Change in Agitation (CGIC) [ Time Frame: 12 weeks ]The ADCS-CGIC-A is the primary outcome measure. It will be anchored to disruptive agitation, the target behaviors in this study. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a direct examination of the participant and an interview of the participant's primary caregiver and other LTC facility staff. The participant is rated on a 7-point Likert scale. Scores can range from 1 (improvement) to 7 (worsening).
- Neuropsychiatric Inventory-Nursing Home version (NPI-NH) [ Time Frame: 12 weeks ]
- Neuropsychiatric Inventory (home based) (NPI) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710642
|United States, Arizona|
|Banner Sun Health Research Institute|
|Sun City, Arizona, United States, 85351|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|University of California, San Diego (UCSD)|
|San Diego, California, United States, 92093|
|Alta California Medical Group|
|Simi Valley, California, United States, 93065|
|Stanford, California, United States, 94305|
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40506|
|United States, Maine|
|Northern Light/Acadia Hospital Eastern Maine Medical Center|
|Bangor, Maine, United States, 04401|
|United States, New York|
|VAMC: James J Peters|
|Bronx, New York, United States, 10468|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, South Carolina|
|Roper St. Francis Hospital|
|Charleston, South Carolina, United States, 29401|
|United States, Texas|
|University of Texas, Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104-2499|
|University of Washington|
|Seattle, Washington, United States, 98108|