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

Sponsored by Virginia Commonwealth University

Phase Quota
Phase 2

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 Start Date: July 2011

Estimated Completion Date: April 2014

Specialties: Internal Medicine: Clinical Pharmacology,Neurology Neurology: Dementia,Neuro/Psych pharmacology Pharmacy: Drug Trials,Neuro/Psych pharmacology Physician Assistant: Clinical Pharmacology,Neurology

Interventions

  • Drug: R-pramipexole

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

Study Locations And Contact Information

  • University of Kansas Medical Center, Kansas City Kansas

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