Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's response to the study drug by measuring the amount of injury to the cells (oxidative stress) in the blood and spinal fluid and brain imaging before and after treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety/Tolerability and Effects on Cognitive Impairment, Impaired Cerebral Cortical Metabolism and Oxidative Stress of R(+)Pramipexole Administered to Subjects With Early Alzheimer's Disease|
- Number of Patients with Adverse Events [ Time Frame: Every 2 months ] [ Designated as safety issue: Yes ]Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
- Effects on Cognitive Performance [ Time Frame: Baseline and then 6 months thereafter ] [ Designated as safety issue: Yes ]Quantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period.
- Reduction of Oxidative Stress [ Time Frame: Baseline and at 24 weeks after taking study drug ] [ Designated as safety issue: No ]A lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment.
- Changes in cerebral glucose metabolism [ Time Frame: Baseline and at 24 weeks after taking drug ] [ Designated as safety issue: No ]PET 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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
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 Dr. Burns prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
|Contact: Jeffrey M. Burns, MD||913-588-0555|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Jeffrey M. Burns, MD 913-588-0555|
|Principal Investigator: Jeffrey M Burns, MD|
|Principal Investigator:||James P. Bennett, MD, PhD||Virginia Commonwealth University|
|Principal Investigator:||Jeffrey M Burns, MD||University of Kansas|