Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

Parkinson Disease Clinical Trial

— TRIP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643327
• Other study ID #: HREC/2020/QRBW/69379
• Status: Recruiting
• Phase: Phase 2
• Start date: February 9, 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Memory Impairment
• Mild Cognitive Impairment
• Parkinson Disease

Intervention

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.
• Placebo
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.

Locations

Country	Name	City	State
Australia	University of Queensland Centre for Clinical Research	Brisbane	Queensland

Sponsors (5)

Lead Sponsor	Collaborator
The University of Queensland	Cleveland Clinic Lou Ruvo Center for Brain Health, Johns Hopkins University, Queensland University of Technology, Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern separation performance (behavioural outcome)	Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.	Immediately after 2 weeks of treatment
Primary	Hippocampal DG/CA3 subfield activity	Participants' brain activation during the pattern separation fMRI paradigm, as measured by their activation in the critical dentate gyrus (DG)/CA3 subfield of the hippocampus during the critical "lure" trials of the pattern separation task.	Immediately after 2 weeks of treatment