Alzheimer's disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Keppra
Product Name: Keppra
Pharmaceutical Form: Tablet
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Current Sponsor code: UCB CODE LO59
Concentration unit: mg milligram(s)
C
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the anti-epileptic medication Levetiracetam offer benefit to cognition in patients with AD who have not experienced an overt seizure ;Secondary Objective: To determine if use of Levetiracetam is associated with significant side effects in patients with AD that have not experienced an overt seizure To determine if use of Levetiracetam is associated with an effect on mood in patients with AD that have not experienced an overt seizure To determine if use of Levetiracetam is associated with changes in quality of life in patients with AD that have not experienced an overt seizure or a change in the quality of life of their carers To evaluate whether the electroencephalogram can be used as a surrogate marker to better predict which patients with AD may respond to treatment with Levetiracetam ;Primary end point(s): Primary Outcome: Changes in cognition in patients while taking Levetiracetam as measured by computerised assessment of a hippocampal binding memory task;Timepoint(s) of evaluation of this end point: Participants in the ILiAD Study will enter a crossover trial in which they will receive Levetiracetam for 12 weeks and Placebo for 12 weeks. There will be assessments at baseline and at the start of the second phase of the trial (12 weeks). Assessments of efficacy will be made at 8 weeks (comparison to baseline) and at 20 weeks (comparison to 12 week assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes: 1. Determination whether Levetiracetam associates with significant side effects in patients with AD that have not experienced an overt seizure 2. To determine if use of Levetiracetam associates with an effect on mood in patients with AD that have not experienced an overt seizure 3. To determine if use of Levetiracetam associates with changes in quality of life in patients with AD that have not experienced an overt seizure or a change in the quality of life of their carers 4. To evaluate whether the electroencephalogram be used as a surrogate marker to better predict which patients with AD may respond to treatment with Levetiracetam ;Timepoint(s) of evaluation of this end point: Participants in the ILiAD Study will enter a crossover trial in which they will receive Levetiracetam for 12 weeks and Placebo for 12 weeks. There will be assessments at baseline and at the start of the second phase of the trial (12 weeks). End point assessments for secondary objectives 1 to 3 will be made at 8 weeks (comparison to baseline) and at 20 weeks (comparison to 12 week assessment) Assessment of the EEG as a surrogate marker will compare baseline assessment of the EEG with cognitive outcomes at 8 and 20 weeks. Once the trial is unblinded, investigators will determine if there is a predictive value of EEG recording on response to Levetiracetam in study subjects | — |
Countries
United Kingdom
Contacts
Public ContactArjune Sen
University of Oxford
Outcome results
None listed