← Trials/Trial dossier/NCT00161473

CompletedPhase NAResults posted

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

Lead sponsor

University of Washington

Asset

Prazosin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Mean Clinical Global Impression of Change (CGIC) at Last Observation•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID16508-A

Nih5P50AG005136

Nih5R01AG018644

NCT IDNCT00161473

Timeline

Milestones

Study start2001-01 (month precision)

Study first posted2005-09-12estimated

Primary completion2009-09actual (month precision)

Study completion2009-09actual (month precision)

Last update posted2012-08-02estimated

Results first posted2012-08-02estimated

Assets

Drug assets

Prazosin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Behavior / neuropsychiatric

Other clinical outcomes

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation

Time frame:Weeks 2, 4, 6, and 8 (change from Baseline)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation

Time frame:Weeks 2, 4, 6, and 8 (change from Baseline)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Prazosinn=11 Participants	-19	21
Placebon=11 Participants	-2	15

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Mean Clinical Global Impression of Change (CGIC) at Last Observation

Time frame:Week 8

descriptive

Primary/registry result

Mean Clinical Global Impression of Change (CGIC) at Last Observation

Time frame:Week 8

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Prazosinn=11 Participants	2.6	1.0
Placebon=11 Participants	4.5	1.6

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Number of Behavioral Assessment Visits Completed

Time frame:Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)

event count, event

Secondary/protocol endpoint/low confidence

Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation

Time frame:Weeks 2, 4, 6, and 8 (change from Baseline)

change from baseline, improvement

Secondary/registry result/low confidence

Number of Behavioral Assessment Visits Completed

Time frame:Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)

event count, event

Posted result

Group	Value (mean), number of visits	Standard deviation
Prazosinn=12 Participants	4.8	1.6
Placebon=12 Participants	4.5	1.8

Secondary/registry result/low confidence

Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation

Time frame:Weeks 2, 4, 6, and 8 (change from Baseline)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Prazosinn=11 Participants	-9	9
Placebon=11 Participants	-3	5

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID19700947via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.