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| Sponsor: | University of Washington |
|---|---|
| Collaborator: |
National Institute on Aging (NIA) |
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00161473 |
Purpose
The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease and other types of dementia in late life.
| Condition | Intervention |
|---|---|
|
Alzheimer Disease Psychomotor Agitation |
Drug: prazosin Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Alzheimer's in Long-Term Care--Treatment for Agitation |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: prazosin
1-6 mg capsules bid for 8 weeks
Other Name: Minipress
|
| Placebo Comparator: 2 |
Drug: placebo
placebo capsules bid for 8 weeks
|
Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in AD. Because of the success prazosin has had in the treatment of PTSD, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate AD patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lucy Wang, MD | 206-277-5089 | wanglucy@u.washington.edu |
| United States, Washington | |
| Veterans Affairs Puget Sound Health Care System | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Principal Investigator: Elaine R Peskind, MD | |
| Principal Investigator: | Elaine R Peskind, MD | Veterans Affairs Puget Sound Health Care System |
More Information
| Responsible Party: | Elaine R. Peskind, MD, Professor, Director of Clinical Research, Mental Health Service, University of Washington School of Medicine/VA Puget Sound Health Care System |
| ClinicalTrials.gov Identifier: | NCT00161473 History of Changes |
| Other Study ID Numbers: | 16508-A |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
double-blind treatment prazosin |
|
Alzheimer Disease Psychomotor Agitation Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations |
Signs and Symptoms Prazosin Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |