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Compares treatment options for Alzheimer Disease, Early Onset
Official title Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
ClinicalTrials.gov ID: NCT04661280
What this study is testing
What is Donepezil?
Donepezil is an investigational medicine, given as an once-daily, being studied as a potential treatment for alzheimer disease, early onset.
Also referred to as Aricept.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more reimbursed by the French healthcare system, due to a controversy about its efficiency. French health authorities currently preconize a non-rug approach based on cognitive remediation or stimulation.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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 treatment study.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.