NCT03710642

Prazosin for Agitation in Alzheimer's Disease

Prazosin for Disruptive Agitation in Alzheimer's Disease (AD) (PEACE-AD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Alzheimer's Disease Cooperative Study (ADCS) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

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 35 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).

Conditions

• Alzheimer's Disease
• Disruptive Behavior

Interventions

Type	Name	Description
DRUG	Prazosin	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
DRUG	Placebo oral capsule	Placebo capsule matched to appearance of active drug.

Timeline

• Start date: 2018-10-23
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2018-10-18
• Last updated: 2023-02-06
• Results posted: 2023-02-06

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study