Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease

This study has been completed.
University of Kansas Medical Center
Alzheimer’s Drug Discovery Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: June 30, 2011
Last updated: September 1, 2015
Last verified: September 2015
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.

Enrollment: 20
Study Start Date: July 2011
Study Completion Date: April 2014
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.


Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01388478

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Virginia Commonwealth University
University of Kansas Medical Center
Alzheimer’s Drug Discovery Foundation
Principal Investigator: James P. Bennett, MD, PhD Virginia Commonwealth University
Principal Investigator: Jeffrey M Burns, MD University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University Identifier: NCT01388478     History of Changes
Other Study ID Numbers: VCU-KU-ADDF-2011  20101202 
Study First Received: June 30, 2011
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on February 04, 2016