Comparing Donepezil and non-drug treatments for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cognitive Neurology Center
  Paris, France Recruiting

Study contacts

• Study coordinator: DUMURGIER Julien, MD, PhD
• Email: julien.dumurgier@aphp.fr
• Phone: +33140054313

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DNL628 safety, tolerability, and drug behavior in people with early Alzheimer's disease.

  This trial will test DNL628 versus placebo in people with early Alzheimer's disease to see if it is safe, well tolerated, and how the body handles the drug.

  Recruiting at 4 sites Phase 1 Denali Therapeutics Inc. · 's-Hertogenbosch and 3 other locations · NCT07328451

• Targeted magnetic stimulation of the precuneus to slow cognitive decline in Alzheimer's

  This will try repetitive magnetic brain stimulation of the precuneus to see if it slows memory and thinking decline in people aged 50–85 with biomarker-confirmed mild Alzheimer's.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam · NCT07036328

• Exploring how music affects people with Alzheimer's and Parkinson's diseases

  This study looks at how music affects people over 60 with Alzheimer's and Parkinson's diseases compared to healthy older adults to see how it influences their emotions and enjoyment of music.

  Recruiting University Hospital, Montpellier · Montpellier, Hérault and 2 other locations · NCT06688968

• Improving symptoms of mild cognitive impairment and early dementia with brain stimulation

  This study is testing a new brain stimulation treatment combined with mental exercises to see if it can help people with mild cognitive impairment and early dementia feel better.

  Recruiting University of Campania Luigi Vanvitelli · Caserta, Italy · NCT06668610

• Biobank for studying ALS and Alzheimer's diseases

  This study is collecting blood, skin samples, and health information from people to see how genetics might help us understand and find treatments for ALS and Alzheimer's disease.

  Recruiting New York Stem Cell Foundation Research Institute · New York, New York · NCT06203106

• Exploring brain microstructure in early Alzheimer's disease

  This study is trying to see if special brain scans can help identify early signs of Alzheimer's disease in people with mild cognitive issues and those who feel their memory is slipping.

  Recruiting Rennes University Hospital · Rennes · NCT06099587

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.