NCT04570085招募中3 期
Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Effect of a 30-week Caffeine Treatment on Cognition in Alzheimer's Disease at Beginning to Moderate Stages
University Hospital, Lille19 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 248
- 试验地点
- 19
- 主要终点
- Changes in NTB scores
研究概览
简要总结
Sporadic Alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. There is currently no curative treatment available.
Coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. Caffeine pharmacological properties enable its use like an Alzheimer's disease symptomatic treatment. Its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which Alzheimer's patients might be more vulnerable.
The main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in Alzheimer's disease dementia at beginning to moderate stage (MMSE 16-24).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 at screening
- •Probable Alzheimer dementia according to the criteria of the National Institute on Aging-Alzheimer's Association; diagnosis must be supported by brain imaging (CT or MRI) and blood test (including ionogram, kidney and liver function, calcemia, CRP, TSH, B12 vitamins and folates) performed in routine care
- •MMSE score ≥16
- •Presence of an informant and caregiver, living with the patient
- •IAChE and/or Memantine treatment non-compulsory ; If implemented it must be effective and stable for 2 months before the selection visit and must remain stable for the duration of the study
排除标准
- •Patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinated sodas, chocolate in large quantities)
- •Current major depressive episode according to DSM-5 criteria
- •Another chronic pathology of the central nervous system
- •Major anxiety according to the clinician (consistent with the corresponding nPI-R items that must indicate a severity >2 and an impact >3)
- •Sleep disorders defined by severity and an impact on NPI-R; a patient fitted for OSA may be included if the device has been in use for 3 months and well tolerated (stable)
- •Decompensated heart disease or severe rhythm disorder (excluding slow, treated and stable chronic atrial fibrillation)
- •Active smoking
- •For childbearing women : pregnancy in progress or planned (A pregnancy test will be performed)
- •Patients who take forbidden treatment :
- •Psychotropic treatments introduced or modified < 2 months before inclusion
- •Chronic use of CYP1A2 inducing or inhibiting drugs
- •All caffeine-containing specialties
- •Drugs that influence caffeine metabolism
- •Drugs that may interact with caffeine
研究组 & 干预措施
placebo
Placebo Comparator
after a 3 weeks up titration period, 2 capsules per day during 27 weeks
干预措施: Placebo (Drug)
Caffeine
Experimental
after a 3 weeks up titration period, 1 capsule of 200 mg twice a day during 27 weeks (ie 400mg/day)
干预措施: Caffeine (Drug)
结局指标
主要结局
Changes in NTB scores
时间窗: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment
次要结局
- Caffeine treatment effect on TAP scores(30 weeks after randomization)
- persistent effect of caffeine treatment on TAP scores after a 6 weeks wash out period(36 weeks after randomization)
- Caffeine effect heterogeneity: impact of caffeine metabolism speed(30 weeks after randomization)
- Caffeine treatment effect on Epworth score(30 weeks after randomization)
- Caffeine treatment effect on QoL-AD score(30 weeks after randomization)
- Caffeine treatment effect on DAD-6 score(30 weeks after randomization)
- persistent effect of caffeine treatment on Epworth score after a 6 weeks wash out period(36 weeks after randomization)
- persistent effect of caffeine treatment on Zarit score after a 6 weeks wash out period(36 weeks after randomization)
- Caffeine treatment effect on MMSE score(30 weeks after randomization)
- Caffeine treatment effect on CGIC score(30 weeks after randomization)
- Caffeine treatment effect on Zarit score(30 weeks after randomization)
- persistent effect of caffeine treatment on MMSE score after a 6 weeks wash out period(36 weeks after randomization)
- persistent effect of caffeine treatment on QoL-AD score after a 6 weeks wash out period(36 weeks after randomization)
- Caffeine effect heterogeneity: impact of gender(30 weeks after randomization)
- Caffeine treatment effect on NTB subscores(30 weeks after randomization)
- persistent effect of caffeine treatment on NTB subscores after a 6 weeks wash out period(36 weeks after randomization)
- Caffeine safety profile: NPI scores(30 weeks after randomization)
- Caffeine safety profile: heart beat(30 weeks after randomization)
- persistent effect of caffeine treatment on DAD-6 score after a 6 weeks wash out period(36 weeks after randomization)
- Caffeine effect heterogeneity: impact of AD treatment(30 weeks after randomization)
- Caffeine effect heterogeneity: impact of ApoE4 status(30 weeks after randomization)
- Caffeine safety profile: blood pressure(30 weeks after randomization)
- Caffeine and its derivatives concentrations in blood samples(30 weeks after randomization)
研究者
研究点 (19)
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