EUCTR2016-003109-32-GB进行中（未招募）1 期
An investigation of Levetiracetam in Alzheimer’s Disease (ILiAD): a proof of concept study - The ILiAD Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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