← Trials/Trial dossier/NCT01126099

CompletedPhase NAResults posted

Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Asset

Prazosin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change•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 ID1R01AG033133-01A1https://reporter.nih.gov/quickSearch/1R01AG033133-01A1

Nih5R01AG033133

NCT IDNCT01126099

Timeline

Milestones

Study start2010-03 (month precision)

Study first posted2010-05-19estimated

Primary completion2014-03actual (month precision)

Study completion2014-03actual (month precision)

Last update posted2015-05-21estimated

Results first posted2015-05-21estimated

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 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

Exclusion criteria

•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

•Exclusionary medications: current treatment with prazosin, other alpha-1 blockers (trazodone, sildenafil, vardenafil or tadalafil)

•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.

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 Score

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change in Neuropsychiatric Inventory Score

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Prazosinn=11 Participants	-23.4	3.7
Placebon=9 Participants	-16.6	4.5

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

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

Time frame:12 Weeks after Baseline

descriptive

Primary/registry result

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

Time frame:12 Weeks after Baseline

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Prazosinn=11 Participants	2.5	.25
Placebon=8 Participants	2.43	.28

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change in Brief Psychiatric Rating Scale Total Score

Time frame:12 Weeks after Baseline

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Days in Study

Time frame:12 weeks after Baseline

event count, event

Secondary/registry result/low confidence

Change in Brief Psychiatric Rating Scale Total Score

Time frame:12 Weeks after Baseline

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Prazosinn=11 Participants	-9.8	2.3
Placebon=9 Participants	-7.7	2.8

Secondary/registry result/low confidence

Days in Study

Time frame:12 weeks after Baseline

event count, event

Posted result

Group	Value (mean), days	Standard deviation
Prazosinn=11 Participants	87	8
Placebon=9 Participants	79	9

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.