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

Phase 1

• Conditions: Alzheimer's disease; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003109-32-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-16
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.
•In the Investigator’s opinion, is able and willing to comply with all trial requirements.
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
•Reliable carer available

Carer of participant with AD
•Male or Female aged 18 and above.
•Principal carer for the participant with AD
• Able to attend all home visit

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

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
Contraindications, warnings and special precautions to Levetiracetam use are not described further in the protocol and the investigator should refer to the Standard Product Characteristics
•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
•Participant with life expectancy of less than 6 months, or is inappropriate for placebo medication.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks will also be excluded

Carer of participant with AD
•Carer has significant medical illness that will preclude adequate data capture during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified