Trial Outcomes & Findings for Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease (NCT NCT01126099)

Last Updated: 2015-05-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

12 Weeks after Baseline

Results posted on

2015-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	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
Double Blind Phase STARTED	11	9
Double Blind Phase COMPLETED	7	7
Double Blind Phase NOT COMPLETED	4	2
Open-label Extension STARTED	5	7
Open-label Extension COMPLETED	4	6
Open-label Extension NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prazosin n=11 Participants 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 n=9 Participants 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 n=20 Participants Total of all reporting groups
Age, Continuous	82.4 years STANDARD_DEVIATION 10.5 • n=5 Participants	78.7 years STANDARD_DEVIATION 8.2 • n=7 Participants	80.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Total Neuropsychiatric Inventory score	43.5 units on a scale STANDARD_DEVIATION 16.2 • n=5 Participants	40.9 units on a scale STANDARD_DEVIATION 18.9 • n=7 Participants	42.4 units on a scale STANDARD_DEVIATION 17.1 • n=5 Participants
Brief Psychiatric Rating Scale	45.4 units on a scale STANDARD_DEVIATION 9.1 • n=5 Participants	44.2 units on a scale STANDARD_DEVIATION 9.5 • n=7 Participants	44.9 units on a scale STANDARD_DEVIATION 9.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks after Baseline

Population: 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.

Outcome measures

Outcome measures
Measure	Prazosin n=11 Participants 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 n=8 Participants 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
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change	2.5 units on a scale Standard Deviation .25	2.43 units on a scale Standard Deviation .28

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Prazosin n=11 Participants 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 n=9 Participants 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
Change in Neuropsychiatric Inventory Score	-23.4 units on a scale Standard Deviation 3.7	-16.6 units on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: 12 Weeks after Baseline

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.

Outcome measures

Outcome measures
Measure	Prazosin n=11 Participants 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 n=9 Participants 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
Change in Brief Psychiatric Rating Scale Total Score	-9.8 units on a scale Standard Deviation 2.3	-7.7 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 12 weeks after Baseline

Population: 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).

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).

Outcome measures

Outcome measures
Measure	Prazosin n=11 Participants 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 n=9 Participants 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
Days in Study	87 days Standard Deviation 8	79 days Standard Deviation 9

Adverse Events

Prazosin

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Lucy Wang

VA Puget Sound

Phone: 206-277-5089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prazosin n=11 participants at risk 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 n=9 participants at risk 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
Nervous system disorders drowsiness	63.6% 7/11 • Number of events 7 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	11.1% 1/9 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
General disorders low energy	36.4% 4/11 • Number of events 4 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	44.4% 4/9 • Number of events 4 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
General disorders dizziness	45.5% 5/11 • Number of events 5 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	11.1% 1/9 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Blood and lymphatic system disorders lower extremity edema	27.3% 3/11 • Number of events 3 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	22.2% 2/9 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Nervous system disorders headache	27.3% 3/11 • Number of events 3 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	11.1% 1/9 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Musculoskeletal and connective tissue disorders musculoskeletal pain	18.2% 2/11 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	22.2% 2/9 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Renal and urinary disorders urinary tract infection	9.1% 1/11 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	33.3% 3/9 • Number of events 3 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
General disorders decreased appetite	18.2% 2/11 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	11.1% 1/9 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Gastrointestinal disorders nausea	18.2% 2/11 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	11.1% 1/9 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Gastrointestinal disorders vomiting	9.1% 1/11 • Number of events 1 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	22.2% 2/9 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Infections and infestations wound infection	0.00% 0/11 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	33.3% 3/9 • Number of events 3 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Gastrointestinal disorders diarrhea	18.2% 2/11 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	0.00% 0/9 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Gastrointestinal disorders gastrointestinal discomfort	18.2% 2/11 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	0.00% 0/9 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Psychiatric disorders increased agitation	0.00% 0/11 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	22.2% 2/9 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
Renal and urinary disorders nocturnal enuresis	18.2% 2/11 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	0.00% 0/9 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.
General disorders sleep disturbance	0.00% 0/11 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.	22.2% 2/9 • Number of events 2 • 12 weeks. Known, common side effects for prazosin were specifically queried at each study visit.