Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease (TRIP)
Status and phase
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Treatments
Details and patient eligibility
About
The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.
Enrollment
Sex
Volunteers
Inclusion criteria
- Parkinson's Disease patients with amnestic Mild Cognitive Impairment
- Parkinson's Disease patients with no memory impairment
- Healthy volunteers
- All participants must be eligible to take MRI scans
Exclusion criteria
- Dementia
- Contraindication to having MRI
- Bipolar disorder, Schizophrenia, Alcohol or substance abuse
- Major depression
- Suicidal Ideation
- Difficulty complying with protocol requirements
- Significant non-PD neurological disease
- Vascular dementia
- Sensitivity to levetiracetam
- Use of anticonvulsant medications
- Use of other excluded medications
- Severe renal impairment
- Clinically significant abnormalities in B12 or thyroid function test (below normative range for elderly)
- Females of childbearing potential
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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