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Clinical Trials/2024-515038-34-00
2024-515038-34-00
Recruiting
Phase 4

CHOLINE-2 - Donepezil Versus Non-drug Treatment in Alzheimer's Disease

Assistance Publique Hopitaux De Paris3 sites in 1 country240 target enrollmentStarted: October 24, 2024Last updated:
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Overview

Phase
Phase 4
Status
Recruiting
Enrollment
240
Locations
3
Primary Endpoint
Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the cognitive efficiency at 6 months of daily intake of donepezil compared to the usual non-drug management by course of treatment.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

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.
  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Difference at 6 months in scores, ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Pr Julien DUMURGIER

Scientific

Assistance Publique Hopitaux De Paris

Study Sites (3)

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