DONEPEZIL for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Diagnosis of Alzheimer's disease according to the 2014 IWG-2 criteria.\n- Covered by social security.\n- Age ≥ 50 years old.\n- Lack of legal protection measure (guardianship, curatorship).\n- MMSE score ≥ 10 on inclusion.\n- Aβ42 in the CSF or abnormal Aβ40 / Aβ42 ratio according to the local cut-offs of the different centers.\n- Phosphorylated tau in the CSF abnormal according to the local cut-offs of the different centers.\n- Presence of a family companion or a person at home who can ensure compliance with treatment in the event of an MMSE score <20.\n- Sufficient command of the French language for the taking of neuropsychological tests."}

Exclusion criteria

• {"criterion_text":"- Other cause of major neurocognitive impairment.\n- History of epileptic disease.\n- History of neuroleptic malignant syndrome\n- History of asthma or obstructive bronchopulmonary disease.\n- Severe hepatic impairment\n- 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).\n- Participation in other interventional research\n- Previous symptomatic treatment of Alzheimer's disease\n- Known hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the SPC.\n- 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.\n- Family or personal history of QTc prolongation, or a Fridericiacorrected QT interval (QTcF) > 450 msec for men and > 470 msec for women.\n- Use of concomitant medications known to prolong the QTc interval,\n- History of relevant pre-existing cardiac pathology (e.g. uncompensated heart failure, recent myocardial infarction, bradyarrhythmias) or electrolyte disorders (hypokalaemia, hypomagnesaemia).\n- Patients at particular risk of ulceration, history of ulcer disease, or receiving concomitant treatment with non-steroidal anti-inflammatory drugs.\n- Patients at risk of urinary retention."}

Primary endpoints

• {"endpoint_text":"- Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.","definition_or_measurement_approach":"Change in MMSE score from baseline (inclusion) to 6 months comparing the donepezil arm versus the usual course of care arm."}

Secondary endpoints

• {"endpoint_text":"- Difference at 6 months in scores, ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.","definition_or_measurement_approach":"Difference in the listed clinical scale scores at 6 months between treatment arms (ADAS-Cog, CDR, ADCS-ADL, quality of life measures, ZARIT)."}

France

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

537

Number Of Sites

7

Number Of Participants

240

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France