Informations générales (source: ClinicalTrials.gov)
Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study (CHOLINE-2)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2022
août 2026
05 avril 2025
Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more
reimbursed by the French healthcare system, due to a controversy about its efficiency.
French health authorities currently preconize a non-rug approach based on cognitive
remediation or stimulation.
The aim of this study is to compare the efficiency of the 2 approaches (non-drug versus
donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | DUMURGIER Julien | 18/04/2025 07:55:37 | Contacter | ||
| AP-HP - Hôpital Bichat | DUMURGIER Julien | 18/04/2025 07:55:37 | Contacter | ||
| AP-HP - Hôpital Broca-La Rochefoucauld-La Collégiale | DUMURGIER Julien | 18/04/2025 07:55:37 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | DUMURGIER Julien | 18/04/2025 07:55:37 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | DUMURGIER Julien | 18/04/2025 07:55:37 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Sarah BENISTY | 21/06/2024 13:34:47 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cognitive Neurology Center - 75010 - Paris - France | DUMURGIER Julien, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Diagnosis of Alzheimer's disease according to the IWG-2 criteria.
- Age ≥ 50 years.
- Absence of legal protection measures (guardianship, curatorship).
- MMSE score ≥ 10 at inclusion.
- abnormal values for Aβ42 in the CSF or Aβ40 / Aβ42 ratio.
- abnormal values for phosphorylated Tau in CSF
- Presence of a family carer or a person at home who can ensure compliance with
treatment if MMSE score <20.
- French native speaker.
- Diagnosis of Alzheimer's disease according to the IWG-2 criteria.
- Age ≥ 50 years.
- Absence of legal protection measures (guardianship, curatorship).
- MMSE score ≥ 10 at inclusion.
- abnormal values for Aβ42 in the CSF or Aβ40 / Aβ42 ratio.
- abnormal values for phosphorylated Tau in CSF
- Presence of a family carer or a person at home who can ensure compliance with
treatment if MMSE score <20.
- French native speaker.
- Other cause of dementia.
- Previous use of symptomatic treatment for Alzheimer's disease.
- Hypersensitivity to donepezil hydrochloride or to any of the excipients listed in
the SPC.
- Cardiological contraindication after possible opinion of a cardiologist, at the
initiative of the investigator, in particular bradycardia, sinus disease or other
supra-ventricular conduction abnormalities such as sinoatrial or atrioventricular
block.
- Taking concomitant medications known to prolong the interval QTc
- Patients at particular risk of ulcer, known ulcer disease or receiving concomitant
treatment with non-steroidal anti-inflammatory drugs.
- Patient at risk of urinary retention.
- History of epileptic disease.
- History of neuroleptic malignant syndrome.
- History of asthma or obstructive bronchopulmonary disease.
- Severe hepatic impairment.
- Taking one of the following treatments:
- CYP3A4 inhibitors, such as ketonazole.
- 2D6 inhibitors, such as quinidine.
- CYP3A4 inhibitors, such as itraconazole and erythromycin.
- CYP2D6 inhibitors, such as fluoxetine.
- Enzyme inducers such as rifampicin, phenytoin, carbamazepine.
- Antiarrhythmic class IA agents
- Antiarrhythmic class III agents
- other Antipsychotics such as phenothiazine, sertindole, pimozide, ziprasidone.
- some antiobiotics such as clarithromycine, erythromycine, levofloxacine,
moxifloxacine.
- Participation in another interventional study.