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: National Institute on Aging (NIA)

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; and documented physical, neurological, and
   other examinations and laboratory tests. At Screening, physical, neurological and
   other examinations; and laboratory tests will be performed as possible and tolerated
   by the agitated participants. Brain imaging is not a requirement.

   2. Participants must reside in either a participating LTC or at home with full-time
   caregiving.

   3. Participants must have disruptive agitation significant enough to disrupt caregiving
   and, in the opinion of the Site Principal Investigator, to justify further treatment.
   Disruptive agitation, defined as having any combination of the following target
   behaviors, 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), must have occurred nearly daily during the previous week and at
   least intermittently for 4 weeks prior to screening, documented on the Behavioral
   Inclusion Criteria Checklist at Screening. Target behaviors may be any combination of
   the listed domains as long as they meet the above-described criteria for frequency and
   severity.

   4. Psychotropic medication, if used, should be stable for at least 2 weeks prior to
   randomization.

   5. If taking cholinesterase inhibitor and/or memantine, must be on stable dose(s) for 3
   months prior to randomization.

   6. During the week before randomization, the above-described behaviors must be rated as
   of at least "moderate" severity. These behaviors must be problematic in that they
   cause participant and caregiver distress and/or interfere with essential care or
   disrupt their living environment.

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. (Note: anticonvulsants prescribed for
   disruptive agitation are acceptable).

   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, and avanafil.

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