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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG033133 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| VA Puget Sound Health Care System | FED |
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A study of outpatient participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication that is commonly used to treat people with high blood pressure. Research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prazosin | Experimental | 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 | Placebo Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prazosin | Drug | 4 mg capsules twice daily for 12 weeks |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change | 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. | 12 Weeks after Baseline |
| Change in Neuropsychiatric Inventory Score | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Psychiatric Rating Scale Total Score | 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. | 12 Weeks after Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine R Peskind, MD | University of Washington, VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Prazosin: 4 mg capsules twice daily for 12 weeks |
| FG001 | 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. Placebo: Placebo capsules twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double Blind Phase |
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| Open-label Extension |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Prazosin: 4 mg capsules twice daily for 12 weeks |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change | 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. | Any participant who had at least one follow-up assessment was included in the analysis. One participant in the Placebo group did not return for follow-up, and therefore was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks after Baseline |
|
12 weeks.
Known, common side effects for prazosin were specifically queried at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Prazosin: 4 mg capsules twice daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drowsiness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucy Wang | VA Puget Sound | 206-277-5089 | wanglucy@u.washington.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011224 | Prazosin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo capsules twice daily for 12 weeks |
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| Days in Study |
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). |
| 12 weeks after Baseline |
| NOT COMPLETED |
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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. Placebo: Placebo capsules twice daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Total Neuropsychiatric Inventory score | 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. | Mean | Standard Deviation | units on a scale |
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| Brief Psychiatric Rating Scale | The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms. | Mean | Standard Deviation | units on a scale |
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| OG001 | 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. Placebo: Placebo capsules twice daily for 12 weeks |
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| Secondary | Change in Brief Psychiatric Rating Scale Total Score | 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. | One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline. | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks after Baseline |
|
|
|
| Primary | Change in Neuropsychiatric Inventory Score | 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. | One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Secondary | Days in Study | 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). | 7 participants in the prazosin group were in the double-blind phase longer than 12 weeks (84 days). 4 participants in the placebo group were in the double-blind phase longer than 12 weeks (84 days). | Posted | Mean | Standard Deviation | days | 12 weeks after Baseline |
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|
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | 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. Placebo: Placebo capsules twice daily for 12 weeks | 0 | 9 | 9 | 9 |
| low energy | General disorders | Systematic Assessment |
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| dizziness | General disorders | Systematic Assessment |
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| lower extremity edema | Blood and lymphatic system disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| decreased appetite | General disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| wound infection | Infections and infestations | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| gastrointestinal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| increased agitation | Psychiatric disorders | Non-systematic Assessment |
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| nocturnal enuresis | Renal and urinary disorders | Non-systematic Assessment |
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| sleep disturbance | General disorders | Non-systematic Assessment |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |