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

NCT04661280 | Recruiting Phase 3

• 1 other identifier: APHP201183
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Alzheimer Disease, Early Onset

Keywords

Alzheimer Disease; Donepezil

Outcome Measures

Primary Outcomes (1)

• Difference of change in the MMSE score

  Difference of change in the MMSE score between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). MMSE is measured at baseline, 6 weeks, 13 weeks, and 26 weeks.

  26 weeks

Secondary Outcomes (5)

• Difference of change in the ADAS-Cog scale

  26 weeks

• Difference of change in the CDR scale

  26 weeks

• Difference of change in the ADL scale

  26 weeks

• Difference of change in the quality of life scale

  26 weeks

• Difference of change in the ZARIT scale

  26 weeks

Study Arms (2)

Cognitive remediation

NO INTERVENTION

Non-drug treatment, cognitive remediation, cognitive stimulation

Cognitive remediation + Donepezil

EXPERIMENTAL

Non-drug treatment, cognitive remediation, cognitive stimulation + Donepezil

Drug: Donepezil

Interventions

Donepezil DRUG

Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.

Also known as: Aricept

Cognitive remediation + Donepezil

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Alzheimer's disease according to the IWG-2 criteria.
• Age ≥ 50 years.
• Absence of legal protection measures (guardianship, curatorship).
• 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.

You may not qualify 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 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.
• D6 inhibitors, such as quinidine.
• CYP3A4 inhibitors, such as itraconazole and erythromycin.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• France Alzheimer: collaborator

Study Sites (1)

Cognitive Neurology Center

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

DUMURGIER Julien, MD, PhD

CONTACT

+33140054313; julien.dumurgier@aphp.fr

PAQUET Claire, MD, PhD

CONTACT

claire.paquet@inserm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: February 10, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)