An investigation of Levetiracetam in Alzheimer’s Disease (ILiAD): a proof of concept study - The ILiAD Study

niversity of Oxford0 sites30 target enrollmentMay 16, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 16, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•All participants:
•Participant is willing and able to give informed consent for participation in the trial.
•Participant has English as their first language
•Participants with AD
•Male or Female, 50 years or above.
•Diagnosed with mild to moderate AD (MMSE 10 to 26\)
•Meets the National Institute of Aging\-Alzheimer's Association criteria for probable AD (2011\)
•Stable dose of current regular medication, including aceytlcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry.
•Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.
•Participant has clinically acceptable blood and urine test results (creatinine clearance \>75 ml/minute; liver function tests \<2x upper limit of normal) and ECG that does not demonstrate conduction block or significant ischaemia within three months of enrolment.

•The participant may not enter the trial if ANY of the following apply
•Participants with AD
•Pre\-existing diagnosis of epilepsy
•Clinical or laboratory evidence of a cause other than AD as a cause of their dementia
•Laboratory evidence of significant renal impairment (creatinine clearance \<75 ml/minute) or liver dysfunction (liver function tests \>2x upper limit of normal) within the preceding three months
•Visual or motor impairment that investigator deems severe enough to impair ability to complete computerised based touch screen task
•Use of anti\-epileptic medication including use for an indication other than epilepsy e.g. for pain or migraine within previous three months
•Other severe neurological or medical condition. Examples include, significant stroke, heart failure, chronic renal failure, chronic liver failure within last 3 months
•Major depression or other significant behavioural disturbance
•Known allergy to Levetiracetam or history of previous adverse reaction to Levetiracetam