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

This study is ongoing, but not recruiting participants.
Sponsor:
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: December 20, 2013
Last verified: December 2013
  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

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
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: December 20, 2013
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 April 22, 2014