CHOLINE-2

RecruitingPhase 3

Donepezil Versus Non-drug Treatment in Alzheimer's Disease.

Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

240

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20

Primary endpoint

•Mini-Mental State Examination (MMSE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAPHP201183

NCT IDNCT04661280

Timeline

Milestones

Study first posted2020-12-10actual

Study start2022-02-10actual

Last update posted2026-02-18actual

Primary completion2026-08estimated (month precision)

Study completion2026-08estimated (month precision)

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Exclusion criteria

•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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Caregiver / quality of life

Other (unclassified)

Global cognition

3 endpoints

Primary/protocol endpoint

Difference of change in the MMSE score

Time frame:26 weeks

Mini-Mental State Examination (MMSE)