Alzheimer's in Long-Term Care--Treatment for Agitation

NCT ID: NCT00161473

Last Updated: 2012-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2009-09-30

Brief Summary

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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 (AD) and other types of dementia in late life.

Detailed Description

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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 Alzheimer's disease. Because of the success prazosin has had in the treatment of Posttraumatic Stress Disorder, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate Alzheimer's disease patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.

Conditions

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Alzheimer Disease Psychomotor Agitation

Keywords

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double-blind treatment prazosin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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prazosin

Group Type ACTIVE_COMPARATOR

prazosin

Intervention Type DRUG

Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.

Duration was 8 weeks.

placebo (inert substance)

Group Type PLACEBO_COMPARATOR

placebo (inert substance)

Intervention Type DRUG

Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.

Interventions

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prazosin

Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.

Duration was 8 weeks.

Intervention Type DRUG

placebo (inert substance)

Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.

Intervention Type DRUG

Other Intervention Names

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Minipress

Eligibility Criteria

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Inclusion Criteria

* No age limit
* probable/possible Alzheimer's disease diagnosis
* disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
* no hypotension
* no concurrent use of alpha-1-blockers
* no delirium, schizophrenia, mania, psychotic symptoms.

Exclusion Criteria

* Cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
* Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
* Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
* Current enrollment in a separate investigational drug trial
* 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 (CGIC) 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaine R Peskind, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Affairs Puget Sound Health Care System

Locations

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Veterans Affairs Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Wang LY, Shofer JB, Rohde K, Hart KL, Hoff DJ, McFall YH, Raskind MA, Peskind ER. Prazosin for the treatment of behavioral symptoms in patients with Alzheimer disease with agitation and aggression. Am J Geriatr Psychiatry. 2009 Sep;17(9):744-51. doi: 10.1097/JGP.0b013e3181ab8c61.

Reference Type RESULT
PMID: 19700947 (View on PubMed)

Other Identifiers

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5R01AG018644

Identifier Type: NIH

Identifier Source: secondary_id

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5P50AG005136

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16508-A

Identifier Type: -

Identifier Source: org_study_id