- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126099
Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a 24 week study with 14 visits to the research clinic. Approximately 6 of these visits may be done by phone. Additional phone checks are scheduled at the beginning of each 12 week part of the study. Participants will have a 50:50 chance of being on prazosin or placebo in the first 12 weeks of the study. For the second 12 weeks, all participants will take prazosin.
Study visits include a physical and neurological exam; memory testing; interviews with the caregiver about behaviors; and vital signs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98108
- Veterans Affairs Puget Sound Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prazosin
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.
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4 mg capsules twice daily for 12 weeks
Other Names:
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Placebo Comparator: Placebo
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.
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Placebo capsules twice daily for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change
Time Frame: 12 Weeks after Baseline
|
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.
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12 Weeks after Baseline
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Change in Neuropsychiatric Inventory Score
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Brief Psychiatric Rating Scale Total Score
Time Frame: 12 Weeks after Baseline
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Brief Psychiatric Rating Scale score change from Baseline to last observation.
The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains.
The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.
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12 Weeks after Baseline
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Days in Study
Time Frame: 12 weeks after Baseline
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The number of days participants remained in the study during the Double Blind Phase.
Please note that although the length of follow-up designated in the protocol was 12 weeks, a number of participants were in this phase longer (e.g. the dose titration phase took longer than 3 weeks, assessments were delayed due to scheduling conflicts, etc.) Therefore the length of time in the Double Blind Phase can exceed 12 weeks (84 days).
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12 weeks after Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Elaine R Peskind, MD, University of Washington, VA Puget Sound Health Care System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Prazosin
Other Study ID Numbers
- 1R01AG033133-01A1 (U.S. NIH Grant/Contract)
- 5R01AG033133 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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