Interest of adding donepezil to the non-medicinal care pathway recommended in France for Alzheimer's disease: CHOLINE-2 study

Phase 1

• Conditions: ewly diagnosed patient with mild to moderate Alzheimer's disease meeting IWG-2 research diagnostic criteria including positivity for Alzheimer's disease biomarkers.; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-001788-26-FR
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- 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.
- Aß42 in the CSF or abnormal Aß40 / Aß42 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 <20.
- Sufficient command of the French language for the taking of neuropsychological tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Another cause of major neurocognitive disorder.
- Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, presence of 2nd or 3rd degree atrioventricular block.
- Previous treatment of symptomatic Alzheimer's disease.
- Participation in another intervention research

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified