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Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01126099
Recruitment Status : Completed
First Posted : May 19, 2010
Results First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Collaborators:
National Institute on Aging (NIA)
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Prazosin
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

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

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

Period Title: Double Blind Phase
Started 11 9
Completed 7 7
Not Completed 4 2
Period Title: Open-label Extension
Started 5 [1] 7
Completed 4 6
Not Completed 1 1
[1]
2 in the Prazosin arm of the Double Blind Phase elected not to enter the Open-Label extension
Arm/Group Title Prazosin Placebo Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
82.4  (10.5) 78.7  (8.2) 80.7  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
6
  54.5%
7
  77.8%
13
  65.0%
Male
5
  45.5%
2
  22.2%
7
  35.0%
Total Neuropsychiatric Inventory score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 9 participants 20 participants
43.5  (16.2) 40.9  (18.9) 42.4  (17.1)
[1]
Measure Description: 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.
Brief Psychiatric Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 9 participants 20 participants
45.4  (9.1) 44.2  (9.5) 44.9  (9.1)
[1]
Measure Description: The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.
1.Primary Outcome
Title Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change
Hide Description 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.
Time Frame 12 Weeks after Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.5  (.25) 2.43  (.28)
2.Primary Outcome
Title Change in Neuropsychiatric Inventory Score
Hide Description 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.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-23.4  (3.7) -16.6  (4.5)
3.Secondary Outcome
Title Change in Brief Psychiatric Rating Scale Total Score
Hide Description 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.
Time Frame 12 Weeks after Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.8  (2.3) -7.7  (2.8)
4.Secondary Outcome
Title Days in Study
Hide Description 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).
Time Frame 12 weeks after Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: days
87  (8) 79  (9)
Time Frame 12 weeks.
Adverse Event Reporting Description Known, common side effects for prazosin were specifically queried at each study visit.
 
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Prazosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prazosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prazosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      9/9 (100.00%)    
Blood and lymphatic system disorders     
lower extremity edema   3/11 (27.27%)  3 2/9 (22.22%)  2
Gastrointestinal disorders     
nausea   2/11 (18.18%)  2 1/9 (11.11%)  1
vomiting   1/11 (9.09%)  1 2/9 (22.22%)  2
diarrhea   2/11 (18.18%)  2 0/9 (0.00%)  0
gastrointestinal discomfort *  2/11 (18.18%)  2 0/9 (0.00%)  0
General disorders     
low energy   4/11 (36.36%)  4 4/9 (44.44%)  4
dizziness   5/11 (45.45%)  5 1/9 (11.11%)  1
decreased appetite   2/11 (18.18%)  2 1/9 (11.11%)  1
sleep disturbance *  0/11 (0.00%)  0 2/9 (22.22%)  2
Infections and infestations     
wound infection *  0/11 (0.00%)  0 3/9 (33.33%)  3
Musculoskeletal and connective tissue disorders     
musculoskeletal pain *  2/11 (18.18%)  2 2/9 (22.22%)  2
Nervous system disorders     
drowsiness   7/11 (63.64%)  7 1/9 (11.11%)  1
headache   3/11 (27.27%)  3 1/9 (11.11%)  1
Psychiatric disorders     
increased agitation *  0/11 (0.00%)  0 2/9 (22.22%)  2
Renal and urinary disorders     
urinary tract infection *  1/11 (9.09%)  1 3/9 (33.33%)  3
nocturnal enuresis *  2/11 (18.18%)  2 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lucy Wang
Organization: VA Puget Sound
Phone: 206-277-5089
Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT01126099     History of Changes
Other Study ID Numbers: 1R01AG033133-01A1 ( U.S. NIH Grant/Contract )
5R01AG033133 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2010
First Posted: May 19, 2010
Results First Submitted: July 15, 2014
Results First Posted: May 21, 2015
Last Update Posted: May 21, 2015