Evidence map›Paper›PMID 37993889›Full record

ArticlePilot and feasibility studies2023

Levetiracetam for the treatment of mild cognitive impairment in Parkinson's disease: a double-blind controlled proof-of-concept trial protocol.

Nadeeka Dissanayaka, Dana Pourzinal, Gerard J Byrne, Jihyun Yang, Katie L McMahon, Gregory M Pontone, John D O'Sullivan, Robert Adam, Roberta Littleford, Mark Chatfield and 3 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04643327 (Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04643327 phase2recruitingnot on this map

Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study

TypeinterventionalSponsorThe University of QueenslandRan2021 to 2025Enrolled28ConditionsParkinson Disease, Mild Cognitive Impairment, Memory ImpairmentArmsLevetiracetam, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 2 countries.

Nadeeka DissanayakaUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia. n.dissanayaka@uq.edu.au.ORCID http://orcid.org/0000-0002-0164-3337
Dana PourzinalUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Gerard J ByrneUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Jihyun YangUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Katie L McMahonSchool of Clinical Sciences, Queensland University of Technology, Brisbane, QLD, Australia.
Gregory M PontoneDepartment of Neurology, Johns Hopkins University, Baltimore, USA.
John D O'SullivanUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Robert AdamUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Roberta LittlefordUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Mark ChatfieldUQ Centre for Clinical Research, The University of Queensland, Herston, QLD, Australia.
Alexander LehnDepartment of Neurology, Princess Alexandra Hospital, Woolloongabba, Brisbane, QLD, Australia.
Zoltan MariDepartment of Neurology, Johns Hopkins University, Baltimore, USA.
Arnold BakkerDepartment of Neurology, Johns Hopkins University, Baltimore, USA.
The University of Queensland · AUJohns Hopkins University · USCleveland Clinic · USPrincess Alexandra Hospital · AUQueensland University of Technology · AURoyal Brisbane and Women's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMild memory impairment, termed amnestic mild cognitive impairment (aMCI), is associated with rapid progression towards dementia in Parkinson's disease (PD). Studies have shown hyperactivation of hippocampal DG/CA3 subfields during an episodic memory task as a biomarker of aMCI related to Alzheimer's disease. This project investigates the feasibility of a trial to establish the efficacy of a repurposed antiepileptic drug, levetiracetam, in low doses as a putative treatment to target DG/CA3 hyperactivation and improve episodic memory deficits in aMCI in PD. Based on previous work, it is hypothesized that levetiracetam will normalize DG/CA3 overactivation in PD-aMCI participants and improve memory performance.

methodsTwenty-eight PD-aMCI participants, 28 PD participants without memory impairment (PD-nMI), and 28 healthy controls will be recruited. PD-aMCI participants will undertake a 12-week randomized, placebo-controlled, double-blind cross-over trial with a 14-day treatment of 125 mg levetiracetam or placebo twice daily, separated by a 4-week washout period. After each treatment period, participants will complete an episodic memory task designed to tax hippocampal subregion-specific function during high-resolution functional magnetic resonance imaging (fMRI). PD-nMI and healthy controls will undergo the fMRI protocol only, to compare baseline DG/CA3 subfield activity.

resultsEpisodic memory task performance and functional activation in the DG/CA3 subfield during the fMRI task will be primary outcome measures. Global cognition, PD severity, and adverse events will be measured as secondary outcomes. Recruitment, eligibility, and study completion rates will be explored as feasibility outcomes.

conclusionsThis study, the first of its kind, will establish hippocampal subregion functional impairment and proof of concept of levetiracetam as an early therapeutic option to reduce dementia risk in PD.

trial registrationClinicalTrials.gov, NCT04643327 . Registered on 25 November 2020.

Indexed as

DementiaEpisodic memoryfMRIHippocampusLevetiracetamParkinson’s disease

Identifiers

PMID37993889
PMCPMC10664284
OpenAlexW4388911422

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.