An Investigation of Levetiracetam in Alzheimer's Disease

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Northumberland, Tyne and Wear NHS Foundation Trust; Oxford Health NHS Foundation Trust; Oxford University Hospitals NHS Trust; UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

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