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Trial record 77 of 101 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Prazosin for Agitation in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03710642
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)

Brief 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


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Disruptive Behavior Drug: Prazosin Drug: Placebo oral capsule Phase 2

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 defined as having at least one of any of the following target behaviors with ≥ moderately severe rating at least 5 times per week for a minimum of 4 weeks: 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) in approximately 186 Alzheimer's disease (AD) residents in long-term care (LTC) settings. LTC is defined as assisted living or skilled nursing facility. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prazosin for Disruptive Agitation in Alzheimer's Disease (AD) (PEACE-AD)
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
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

  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.

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
Other Names:
  • Prazosin HCl
  • Minipress

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Neuropsychiatric Inventory-Nursing Home version (NPI-NH) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females with probable or possible AD by NINCDS-ADRDA criteria utilizing medical history; medical records review; physical, neurological, and psychiatric exam; and screening laboratory tests, who are residing in a LTC facility. Brain imaging is not a requirement.
  2. At Baseline (BL), participants must have disruptive agitation (documented on the Behavioral Inclusion Criteria Checklist and detailed on the ADCS-CGIC-A BL Worksheet) defined as having at least one of the following target behaviors with > moderately severe rating at least 5 times per week for a minimum duration of 4 weeks: a) irritability, b) physically and/or verbally aggressive behavior, c) physically resistive to necessary care, and/or d) pressured motor activity (e.g., pressured pacing). These behaviors must be problematic in that they cause participant and caregiver distress and/or interfere with essential care or disrupt the LTC environment. Target behaviors may be any combination of the listed domains, as long as there are 5 or more instances per week of at least moderate severity.
  3. Psychotropic medication, if used, should be stable for at least 2 weeks prior to randomization.
  4. If taking cholinesterase inhibitor and/or memantine, must be on stable dose(s) for 3 months prior to randomization.
  5. Must be able to swallow capsules whole.

Exclusion Criteria:

  1. History of schizophrenia, schizoaffective disorder, or bipolar disorder according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
  2. Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumor.
  3. Dementia other than probable or possible AD per NINCDS-ADRDA criteria, such as human immunodeficiency virus (HIV) dementia, Creutzfeldt-Jakob disease, frontotemporal dementia, multiple cerebral infarctions, or normal pressure hydrocephalus.
  4. Current treatment for seizure disorder.
  5. Abnormal laboratory values with clinical significance in the opinion of the site Principal Investigator.
  6. Current unstable medical illness including delirium, worsening congestive heart failure, unstable angina, recent myocardial infarction (within the past 3 months), acute infectious disease, severe renal or hepatic failure, severe respiratory disease, metastatic cancer, or other conditions that, in the Site Principal Investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
  7. Bedbound; participants may be ambulatory or use a wheelchair.
  8. Absence of any comprehensible language.
  9. Participation in another clinical trial for an investigational agent and took at least one dose of study drug (unless unblinded to placebo) within 12 weeks prior to screening. (The end of a previous investigational trial is defined as the date of the last dose of an investigational agent).
  10. Preexisting recurrent hypotension (systolic blood pressure [BP] <110).
  11. Preexisting orthostatic hypotension (>20 mmHg drop in systolic BP following 2 minutes of standing posture [or sitting if unable to stand], accompanied by dizziness, lightheadedness, or syncope).
  12. A 2-week washout is required prior to BL for the following exclusionary medications: prazosin or other alpha-1 blocker, sildenafil, vardenafil, tadalafil, avanafil, and trazodone.
  13. Women of childbearing potential (must be at least 2 years post-menopausal or surgically sterile for inclusion).
  14. The participant may not be an immediate family member of personnel directly affiliated with this study, the study site or study funding agency. Immediate family member is defined as a spouse, parent, child, or sibling, any of whom may be related by blood, adoption, or marriage.
  15. Participants whom the Site Principal Investigator deems to be otherwise unsuitable for participation.

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Information from the National Library of Medicine

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


Contacts
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Contact: Genny Matthews 858-246-1318 brainlink@ucsd.edu
Contact: Rosemary Morrison brainlink@ucsd.edu

Locations
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United States, California
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
University of California, San Diego (UCSD) Not yet recruiting
San Diego, California, United States, 92093
Stanford University Not yet recruiting
Stanford, California, United States, 94305
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Amir Elbiheary    859-218-3775    ael243@uky.edu   
Principal Investigator: Ronan Murphy, MD         
United States, South Carolina
Roper St. Francis Not yet recruiting
Charleston, South Carolina, United States, 29401
United States, Texas
University of Texas, Southwestern MC at Dallas Not yet recruiting
Dallas, Texas, United States, 75390
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
National Institute on Aging (NIA)
VA Puget Sound Health Care System

Publications:

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Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT03710642     History of Changes
Other Study ID Numbers: ADC-042-PRAZ
5U19AG010483 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alzheimer's Disease Cooperative Study (ADCS):
Dementia
Agitation
PEACE-AD

Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Problem Behavior
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Behavioral Symptoms
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs