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Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01126099
First received: May 17, 2010
Last updated: May 19, 2015
Last verified: May 2015
Results First Received: July 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Prazosin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

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


Participant Flow for 2 periods

Period 1:   Double Blind Phase
    Prazosin   Placebo
STARTED   11   9 
COMPLETED   7   7 
NOT COMPLETED   4   2 

Period 2:   Open-label Extension
    Prazosin   Placebo
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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

Total Total of all reporting groups

Baseline Measures
   Prazosin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   9   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 82.4  (10.5)   78.7  (8.2)   80.7  (9.5) 
Gender 
[Units: Participants]
     
Female   6   7   13 
Male   5   2   7 
Total Neuropsychiatric Inventory score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 43.5  (16.2)   40.9  (18.9)   42.4  (17.1) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 45.4  (9.1)   44.2  (9.5)   44.9  (9.1) 
[1] The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change   [ Time Frame: 12 Weeks after Baseline ]

2.  Primary:   Change in Neuropsychiatric Inventory Score   [ Time Frame: 12 weeks ]

3.  Secondary:   Change in Brief Psychiatric Rating Scale Total Score   [ Time Frame: 12 Weeks after Baseline ]

4.  Secondary:   Days in Study   [ Time Frame: 12 weeks after Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: wanglucy@u.washington.edu



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 )
Study First Received: May 17, 2010
Results First Received: July 15, 2014
Last Updated: May 19, 2015