Trial Outcomes & Findings for Alzheimer's in Long-Term Care--Treatment for Agitation (NCT NCT00161473)
NCT ID: NCT00161473
Last Updated: 2012-08-02
Results Overview
The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates "markedly improved," 4 indicates "no change," and 7 indicates "markedly worse."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Week 8
Results posted on
2012-08-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alzheimer's in Long-Term Care--Treatment for Agitation
Baseline characteristics by cohort
| Measure |
Prazosin
n=12 Participants
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
n=12 Participants
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age Continuous
|
83.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
78.1 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
80.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Participants with at least one follow-up behavioral assessment visit were included in this analysis
The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates "markedly improved," 4 indicates "no change," and 7 indicates "markedly worse."
Outcome measures
| Measure |
Prazosin
n=11 Participants
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
n=11 Participants
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
|
|---|---|---|
|
Mean Clinical Global Impression of Change (CGIC) at Last Observation
|
2.6 units on a scale
Standard Deviation 1.0
|
4.5 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Weeks 2, 4, 6, and 8 (change from Baseline)Population: Participants with at least one follow-up behavioral assessment visit were included in this analysis. The mean group change was calculated by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations.
The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms. A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement.
Outcome measures
| Measure |
Prazosin
n=11 Participants
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
n=11 Participants
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
|
|---|---|---|
|
Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation
|
-19 units on a scale
Standard Deviation 21
|
-2 units on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.
Outcome measures
| Measure |
Prazosin
n=12 Participants
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
n=12 Participants
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
|
|---|---|---|
|
Number of Behavioral Assessment Visits Completed
|
4.8 number of visits
Standard Deviation 1.6
|
4.5 number of visits
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, and 8 (change from Baseline)Population: Participants with at least one follow-up behavioral assessment visit were included in this analysis. The mean group change was determined by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations.
The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms. A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement.
Outcome measures
| Measure |
Prazosin
n=11 Participants
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
n=11 Participants
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
|
|---|---|---|
|
Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation
|
-9 units on a scale
Standard Deviation 9
|
-3 units on a scale
Standard Deviation 5
|
Adverse Events
Prazosin
Serious events: 0 serious events
Other events: 6 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
| Measure |
Prazosin
n=12 participants at risk
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
n=12 participants at risk
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
|
|---|---|---|
|
Nervous system disorders
sedation
|
25.0%
3/12 • Number of events 3 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
25.0%
3/12 • Number of events 3 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Nervous system disorders
confusion
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
33.3%
4/12 • Number of events 4 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Vascular disorders
lower extremity edema
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Vascular disorders
hypotension
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Nervous system disorders
headache
|
0.00%
0/12 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
0.00%
0/12 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Psychiatric disorders
hallucinations
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Vascular disorders
dizziness on standing
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
0.00%
0/12 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/12 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from informed consent up until volunteers reached the end of their participation per protocol. Monitoring period was 10-12 weeks (2-4 weeks to start and titrate study drug, plus the 8 week follow-up period).
Adverse effects were collected at each study visit. Study staff inquired about specific symptoms known to be potential side effects of prazosin using a preexisting checklist. Participants and their study companions were also asked about any new changes in health or medications.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place