Alzheimer's in Long-Term Care--Treatment for Agitation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00161473
First received: September 8, 2005
Last updated: June 26, 2012
Last verified: June 2012
Results First Received: February 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alzheimer Disease
Psychomotor Agitation
Interventions: Drug: prazosin
Drug: placebo (inert substance)

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Prazosin Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
Placebo Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.

Participant Flow:   Overall Study
    Prazosin     Placebo  
STARTED     12     12  
COMPLETED     7     6  
NOT COMPLETED     5     6  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
Placebo Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
Total Total of all reporting groups

Baseline Measures
    Prazosin     Placebo     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  83.2  ± 11.5     78.1  ± 10.8     80.6  ± 11.2  
Gender  
[units: participants]
     
Female     5     6     11  
Male     7     6     13  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Clinical Global Impression of Change (CGIC) at Last Observation   [ Time Frame: Week 8 ]

2.  Primary:   Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation   [ Time Frame: Weeks 2, 4, 6, and 8 (change from Baseline) ]

3.  Secondary:   Number of Behavioral Assessment Visits Completed   [ Time Frame: Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8) ]

4.  Secondary:   Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation   [ Time Frame: Weeks 2, 4, 6, and 8 (change from Baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 Y. Wang, M.D.
Organization: VA Puget Sound Healthcare System
phone: 206-277-5089
e-mail: wanglucy@u.washington.edu


Publications of Results:

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00161473     History of Changes
Other Study ID Numbers: 16508-A, 5R01AG018644, 5P50AG005136
Study First Received: September 8, 2005
Results First Received: February 24, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board