Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease (TRIP)
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|ClinicalTrials.gov Identifier: NCT04643327|
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Mild Cognitive Impairment Memory Impairment||Drug: Levetiracetam Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Double-blind randomised-controlled within-subject crossover trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||February 9, 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Active arm
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
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
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
- Pattern separation performance (behavioural outcome) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643327
|University of Queensland Centre for Clinical Research||Recruiting|
|Brisbane, Queensland, Australia, 4029|
|Contact: Dana Pourzinal, BSc 0733465028 firstname.lastname@example.org|