Trial Outcomes & Findings for Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease (NCT NCT01388478)
NCT ID: NCT01388478
Last Updated: 2021-10-12
Results Overview
Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
R(+)Pramipexole
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
R(+)Pramipexole
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
R(+)Pramipexole
n=20 Participants
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
|
|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 7.9 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 6 monthsLabwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
Outcome measures
| Measure |
R(+)Pramipexole
n=20 Participants
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
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|---|---|
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Number of Patients With Adverse Events
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and then 6 months thereafterQuantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at 24 weeks after taking drugPET Scan will be performed. Changes in cerebral glucose metabolism as a proxy for mitochondrial respiration will be assayed at baseline and 24 weeks. Correlations will be sought with assays of oxidative stress reduction to see if greater reductions in brain oxidative stress are reflected in elevations of cortical 2-FDG.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at 24 weeks after taking study drugA lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment.
Outcome measures
Outcome data not reported
Adverse Events
R(+)Pramipexole
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
R(+)Pramipexole
n=20 participants at risk
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
R-pramipexole: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
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|---|---|
|
Psychiatric disorders
Agitation/irritability
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
General disorders
Tooth problems
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Infections and infestations
Cold symptoms
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Nervous system disorders
Confabulations
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Nervous system disorders
Contusion
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
General disorders
Coughing
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Decreased appetite
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Dreaming
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Nervous system disorders
Falls
|
25.0%
5/20 • Number of events 5 • 6 months
|
|
Nervous system disorders
Hallucinations
|
10.0%
2/20 • Number of events 3 • 6 months
|
|
Nervous system disorders
Increased confusion
|
15.0%
3/20 • Number of events 5 • 6 months
|
|
Psychiatric disorders
Increased depression
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Endocrine disorders
Increased libido
|
15.0%
3/20 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Injury to urethra
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
15.0%
3/20 • Number of events 3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Laceration
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Nervous system disorders
Migraine
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea or vomiting
|
20.0%
4/20 • Number of events 4 • 6 months
|
|
General disorders
Sensation in throat
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Sinus issues
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Nervous system disorders
Sleep disturbance
|
20.0%
4/20 • Number of events 5 • 6 months
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Sweating
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Nervous system disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Weight loss
|
5.0%
1/20 • Number of events 1 • 6 months
|
Additional Information
Jeffrey Burns, M.D., M.S.
University of Kansas Medical Center
Phone: 913-588-0555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place