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ILiAD

CompletedPhase 2

An Investigation of Levetiracetam in Alzheimer's Disease

An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a Proof of Concept Study

Lead sponsor

University of Oxford

Asset

Levetiracetam

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-26•AD symptomatic therapy: stable

Primary endpoint

•Effect of Levetiracetam on hippocampal function

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2016-003109-32

Org study IDIRAS 203849

NCT IDNCT03489044

Timeline

Milestones

Study first posted2018-04-05actual

Study start2018-10-28actual

Primary completion2022-03-21actual

Study completion2022-03-21actual

Last update posted2024-04-24actual

Assets

Drug assets

Levetiracetam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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 acetylcholinesterase 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. Acceptable forms of contraception include: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); total abdominal hysterectomy; barrier methods of contraception (condom or occlusive cap with spermicide); male sterilisation, if the vasectomised partner is the sole partner for the subject; true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception).

•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 willing and available to assist with medication administration as well as to accompany participants during any home visits

Exclusion criteria

•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 for any indication (epilepsy, 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

•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 Carer of participant with AD

•Carer has significant medical illness that will preclude adequate data capture during the study

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Caregiver / quality of life

Other (unclassified)

Behavior / neuropsychiatric

Safety / tolerability / PK

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Effect of Levetiracetam on mood in patients with Alzheimer's disease

Time frame:18 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Effect of Levetiracetam on quality of life in patients with Alzheimer's disease as assessed by their principal carer

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint

Effect of Levetiracetam on quality of life in patients with Alzheimer's disease

Time frame:18 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of participants with treatment related serious adverse events as reported on the serious adverse events proforma

Time frame:18 months

event count, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Effect of Levetiracetam on hippocampal function in patients with Alzheimer's disease as assessed by a computerised test of hippocampal binding

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Determining role of the electroencephalogram in patients with Alzheimer's disease

Time frame:18 months

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.