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An Investigation of Levetiracetam in Alzheimer's Disease

NCT03489044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-04-24

No results posted yet for this study

Summary

The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's disease (AD) in a Phase 2 Clinical Trial.

Levetiracetam is an established anti-epileptic medication that has been approved by NICE (UK) as a first line treatment for focal epilepsy. Levetiracetam is now generic and acts, as all anti-epileptic medications do, by stabilising neuronal networks. However, Levetiracetam appears unique amongst the anti-epileptic medications in being able to stabilise aberrant neuronal networks in Alzheimer's disease. In both animal models of AD and in patients with mild cognitive impairment, Levetiracetam can offer benefit to cognition.

The investigators therefore aim to test whether Levetiracetam, through stabilisation of neuronal networks, may offer benefit to cognition in patients with AD.

Conditions

Interventions

DRUG

Levetiracetam

To up-titrate Levetiracetam to 500mg (two tablets) twice daily followed by maintenance on Levetiracetam 500mg twice daily for four weeks and then down-titrate to nil over four weeks

DRUG

Placebo Oral Tablet

To up-titrate placebo to two tablets twice daily followed by maintenance on placebo two tablets twice daily for four weeks and then down-titrate to nil over four weeks

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • Oxford Health NHS Foundation Trust

    collaborator OTHER_GOV

  • Northumberland, Tyne and Wear NHS Foundation Trust

    collaborator OTHER

  • UCB Pharma

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Arjune Sen, PhD, FRCPE · Nuffield Department of Clinical Neurosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-28
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT03489044 on ClinicalTrials.gov