Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

NCT01126099 | Completed Results DMC

• 2 other identifiers: 1R01AG033133-01A15R01AG033133
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A study of outpatient participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication that is commonly used to treat people with high blood pressure. Research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.

Conditions

Alzheimer's Disease

Keywords

double-blind; treatment; prazosin; Disruptive behaviors in Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change

  This scale represents the raters overall impression of improvement or worsening, and is assessed at the last visit. 1 = Marked improvement, 1 = Moderate improvement, 3 = Minimal improvement, 4 = No change, 5 = Minimal worsening, 6 = Moderate worsening, 7 = Marked worsening.

  12 Weeks after Baseline

• Change in Neuropsychiatric Inventory Score

  Neuropsychiatric Inventory score change from Baseline to last observation.The Neuropsychiatric Inventory is a scale that quantifies behavioral and psychiatric symptoms in patients with dementia. The scale ranges from 0 to 144, with 0 being no symptoms.

  12 weeks

Secondary Outcomes (2)

• Change in Brief Psychiatric Rating Scale Total Score

  12 Weeks after Baseline

• Days in Study

  12 weeks after Baseline

Study Arms (2)

Prazosin

EXPERIMENTAL

In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.

Drug: Prazosin

Placebo

PLACEBO COMPARATOR

In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.

Drug: Placebo

Interventions

Prazosin DRUG

4 mg capsules twice daily for 12 weeks

Also known as: minipress

Prazosin

Placebo DRUG

Placebo capsules twice daily for 12 weeks

Also known as: inert substance

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• No age limit
• Probable or Possible Alzheimer's Disease
• Disruptive agitated behaviors at least twice a week (overly anxious or excited, making offensive comments.....)
• Stable medications for 2 weeks
• Must have a caregiver who spends 10 hours per week caring for the participant and agrees to participate in all evaluation sessions

You may not qualify if:

• Cardiovascular: unstable angina, recent myocardial infarction, preexisting hypotension (systolic BP less than 110) or orthostatic hypotension (≥20 mmHg drop in systolic BP following 2 minutes of standing posture)
• Any unstable medical condition
• Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
• Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• National Institute on Aging (NIA): collaborator
• VA Puget Sound Health Care System: collaborator

Study Sites (1)

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lucy Wang
• Organization: VA Puget Sound

wanglucy@u.washington.edu

206-277-5089

Study Officials

• Elaine R Peskind, MD

  University of Washington, VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 21, 2015
• Results First Posted: May 21, 2015

Record last verified: 2015-05

Locations

US (1)