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

Sponsor

The University of Queensland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04643327

Collaborator

Queensland University of Technology (Other), Johns Hopkins University (Other), Cleveland Clinic Lou Ruvo Center for Brain Health (Other), Royal Brisbane and Women's Hospital (Other)

Enrollment

Location

Arms

33.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Mild Cognitive Impairment Memory Impairment	Drug: Levetiracetam Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double-blind randomised-controlled within-subject crossover trialDouble-blind randomised-controlled within-subject crossover trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 9, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active arm 125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days	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 Comparator: Placebo arm 125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days	Drug: Placebo Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.

Arm

Intervention/Treatment

Experimental: Active arm

125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days

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 Comparator: Placebo arm

125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Pattern separation performance (behavioural outcome) [Immediately after 2 weeks of treatment]
Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.
Hippocampal DG/CA3 subfield activity [Immediately after 2 weeks of treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Queensland Centre for Clinical Research	Brisbane	Queensland	Australia	4029

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nadeeka Dissanyaka, NHMRC Boosting Dementia Research Leadership Fellow, The University of Queensland

ClinicalTrials.gov Identifier:

NCT04643327

Other Study ID Numbers:

HREC/2020/QRBW/69379

First Posted:

Nov 25, 2020

Last Update Posted:

May 3, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Parkinson Disease

Cognitive Dysfunction

Levetiracetam

Study Results

No Results Posted as of May 3, 2021