Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: R-pramipexole
Intervention description: 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 the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Safety; Tolerability; R(+)Pramipexole; Alzheimer's

Summary:

      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.
    

Eligibility 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