Comparing Donepezil and non-drug treatments for 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

This study is testing whether adding the medication Donepezil to standard non-drug care can help people with Alzheimer's disease feel better after six months.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT04661280 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Donepezil, a medication for Alzheimer's disease, against a non-drug treatment approach recommended by French health authorities. It is a randomized multicentric open-label trial that will involve two groups: one receiving standard non-drug care focused on cognitive and social stimulation, and the other receiving the same care plus Donepezil. The study will assess the symptoms of Alzheimer's disease after six months of treatment. Participants will be monitored for their response to both treatment strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older diagnosed with Alzheimer's disease who meet specific cognitive and health criteria.

Not a fit: Patients with other causes of dementia or those who have previously used symptomatic treatments for Alzheimer's disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment approach for managing Alzheimer's disease symptoms.

How similar studies have performed: Other studies have explored similar non-drug approaches, but the comparison with Donepezil in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Paris

• Cognitive Neurology Center — Paris, France (Recruiting)

Study contacts

• Study coordinator: DUMURGIER Julien, MD, PhD

Conditions Alzheimer Disease, Early Onset; Alzheimer Disease; Donepezil