Trial Search Results

Prazosin for Agitation in Alzheimer's Disease

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Alzheimer's Disease Cooperative Study (ADCS)

Collaborator: VA Puget Sound Health Care System

Intervention(s):

  • Drug: Prazosin
  • Drug: Placebo oral capsule

Phase:

Phase 2

Eligibility


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.

   -

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting