Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 55 - Any |
Updated: | 4/21/2016 |
Start Date: | July 2011 |
End Date: | April 2014 |
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
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.
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.
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
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