Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
This study is currently recruiting participants.
Verified January 2012 by Virginia Commonwealth University
Sponsor:
Virginia Commonwealth University
Collaborators:
University of Kansas
Alzheimer’s Drug Discovery Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01388478
First received: June 30, 2011
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: R-pramipexole |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: R(+)pramipexole
Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.
|
Drug: 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 Dr. Burns prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent provided by the participant or the participant's legally acceptable representative
- Age 55 years or older
- Possible/probable Alzheimer's Disease (AD)
- Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. Caregiver must visit with the subject >5 times per week.
- Rosen Modified Hachinski score of 4 or less
- Imaging Study (CT or MRI) compatible with AD or age-related changes (absence of significant abnormalities that may explain cognitive decline, such as multiple lacunar infarcts or a single prior infarct >1 cubic cm, microhemorrhages or evidence of a prior hemorrhage > 1 cubic cm, evidence of cerebral contusion encephalomalacia, aneurysm, vascular malformation, or space occupying lesion such as an arachnoid cyst or brain tumor).
- Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
Exclusion Criteria:
- Significant neurological disease, other than AD, that may affect cognition
- Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
- History of clinically-evident stroke
- Clinically-significant infection within the last 30 days
- Myocardial infarction or symptoms of active coronary artery disease (e.g., angina) in the last two years.
- Uncontrolled hypertension within the last 6 months.
- History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
- History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
- Insulin dependent diabetes mellitus
- Significant pain or musculoskeletal disorder that would prohibit participation in metabolic testing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388478
Contacts
| Contact: Jeffrey M. Burns, MD | 913-588-0555 |
Locations
| 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 | |
Sponsors and Collaborators
Virginia Commonwealth University
University of Kansas
Alzheimer’s Drug Discovery Foundation
Investigators
| Principal Investigator: | James P. Bennett, MD, PhD | Virginia Commonwealth University |
| Principal Investigator: | Jeffrey M Burns, MD | University of Kansas |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01388478 History of Changes |
| Other Study ID Numbers: | VCU-KU-ADDF-2011, 20101202 |
| Study First Received: | June 30, 2011 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Virginia Commonwealth University:
|
Safety Tolerability R(+)Pramipexole Alzheimer's |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Pramipexol Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013