Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
NCT ID: NCT04661280
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2022-02-10
2026-08-31
Brief Summary
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The aim of this study is to compare the efficiency of the 2 approaches (non-drug versus donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.
Detailed Description
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2 arms:
* Standard of care, non-drug approach: following the recommendations of the Alzheimer's disease care by the Frenchh Health Authority. The care is cognitive, psychic, functional or social and centered on the patient and his environment. This care is best carried out by the memory consultations participating in this study and having extensive experience in the care of Alzheimer patients. It is usually based in particular on the prescription of cognitive stimulation sessions by a speech therapist and a mobile Alzheimer specialist team at home for cognitive remediation sessions.
* Donepezil group: Management similar to the previous arm plus addition of Donepezil 5 mg per os once a day for one month and then 10 mg per os once a day until the 6th month.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive remediation
Non-drug treatment, cognitive remediation, cognitive stimulation
No interventions assigned to this group
Cognitive remediation + Donepezil
Non-drug treatment, cognitive remediation, cognitive stimulation + Donepezil
Donepezil
Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.
Interventions
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Donepezil
Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
50 Years
ALL
No
Sponsors
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France Alzheimer
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Cognitive Neurology Center
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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DUMURGIER Julien, MD, PhD
Role: primary
Other Identifiers
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APHP201183
Identifier Type: -
Identifier Source: org_study_id