Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Levetiracetam, Placebo.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Mild Cognitive Impairment, Memory Impairment. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study
Overview
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.
Interventions
- Drug Levetiracetam
Levetiracetam is currently approved in Australia and the U.S.A. for epilepsy. We will be providing levetiracetam in capsule form, 125mg levetiracetam in each capsule. - Drug Placebo
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Primary outcome measures
- Pattern separation performance (behavioural outcome) [Time frame: Immediately after 2 weeks of treatment]
- Hippocampal DG/CA3 subfield activity [Time frame: Immediately after 2 weeks of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- University of Queensland Centre for Clinical Research — Brisbane
Publications
- Dissanayaka N, Pourzinal D, Byrne GJ, Yang J, McMahon KL, Pontone GM, O'Sullivan JD, Adam R, Littleford R, Chatfield M, Lehn A, Mari Z, Bakker A. Levetiracetam for the treatment of mild cognitive impairment in Parkinson's disease: a double-blind controlled proof-of-concept trial protocol. Pilot Feasibility Stud. 2023 Nov 22;9(1):189. doi: 10.1186/s40814-023-01406-y. PMID 37993889
Identifiers
NCT: NCT04643327 · HREC/2020/QRBW/69379