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

NCT04643327 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Queensland University of Technology

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    collaborator UNKNOWN

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • The University of Queensland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2025-01-31
Completion
2025-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643327 on ClinicalTrials.gov