2024-515038-34-00招募中4 期
CHOLINE-2 - Donepezil Versus Non-drug Treatment in Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.
研究概览
简要总结
To evaluate the cognitive efficiency at 6 months of daily intake of donepezil compared to the usual non-drug management by course of treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Alzheimer's disease according to the 2014 IWG-2 criteria.
- •Covered by social security.
- •Age ≥ 50 years old.
- •Lack of legal protection measure (guardianship, curatorship).
- •MMSE score ≥ 10 on inclusion.
- •Aβ42 in the CSF or abnormal Aβ40 / Aβ42 ratio according to the local cut-offs of the different centers.
- •Phosphorylated tau in the CSF abnormal according to the local cut-offs of the different centers.
- •Presence of a family companion or a person at home who can ensure compliance with treatment in the event of an MMSE score <
- •Sufficient command of the French language for the taking of neuropsychological tests.
排除标准
- •Other cause of major neurocognitive impairment.
- •History of epileptic disease.
- •History of neuroleptic malignant syndrome
- •History of asthma or obstructive bronchopulmonary disease.
- •Severe hepatic impairment
- •Taking any of the following medications: > CYP3A4 inhibitors, such as ketonozale. > 2D6 inhibitors, such as quinidine. > CYP3A4 inhibitors such as itraconazole and erythromycin. > CYP2D6 inhibitors, such as fluoxetine. > Enzyme inducers such as rifampin, phenytoin, carbamazepine. > Class IA antiarrhythmics (e.g. quinidine); > Class III antiarrhythmics (e.g. amiodarone, sotalol). > Other antipsychotics (e.g. phenothiazine derivatives, sertindole, pimozide, ziprasidone). > Certain antibiotics (e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin).
- •Participation in other interventional research
- •Previous symptomatic treatment of Alzheimer's disease
- •Known hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the SPC.
- •Cardiological contraindication after possible advice from a cardiologist, at the initiative of the investigator, including bradycardia, sinus disease or other supraventricular conduction abnormalities such as sinoauricular or atrioventricular block.
- •Family or personal history of QTc prolongation, or a Fridericiacorrected QT interval (QTcF) > 450 msec for men and > 470 msec for women.
- •Use of concomitant medications known to prolong the QTc interval,
- •History of relevant pre-existing cardiac pathology (e.g. uncompensated heart failure, recent myocardial infarction, bradyarrhythmias) or electrolyte disorders (hypokalaemia, hypomagnesaemia).
- •Patients at particular risk of ulceration, history of ulcer disease, or receiving concomitant treatment with non-steroidal anti-inflammatory drugs.
- •Patients at risk of urinary retention.
结局指标
主要结局
Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.
Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.
次要结局
- Difference at 6 months in scores, ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.
研究者
Pr Julien DUMURGIER
Scientific
Assistance Publique Hopitaux De Paris
研究点 (3)
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