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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001788-26-FR

Enrollment

120

Registered

2021-05-12

Start date

2021-07-02

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed patient with mild to moderate Alzheimer's disease meeting IWG-2 research diagnostic criteria including positivity for Alzheimer's disease biomarkers. MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: DONEPEZIL CAS Number: 120014-06-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical Form: Tablet I

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the cognitive efficiency at 6 months of daily intake of donepezil compared to the usual non-drug management by course of treatment.;Secondary Objective: Efficacy at 6 months on the different clinical scales used: ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.;Primary end point(s): Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To evaluate the cognitive efficiency at 6 months of daily intake of donepezil compared to the usual non-drug management by course of treatment.;Secondary Objective: Efficacy at 6 months on the different clinical scales used: ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.;Primary end point(s): Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Difference at 6 months in scores, ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

France

Contacts

Public ContactElodie SOLEr

Assistance Publique - Hôpitaux de Paris

elodie.soler@aphp.fr+33(0)1 44 84 17 35

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026