Health TrialsbyHealthPanel

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

ConditionAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Donepezil

    Drug

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Cognitive remediationNo intervention 0 interventions
Group B: Cognitive remediation + DonepezilExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
26 weeks

Secondary outcomes

1

Difference of change in the ADAS-Cog scale

Difference of change in the ADAS-Cog scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). ADAS-Cog scale = Alzheimer's Disease Assessment Scale-Cognitive Subscale, scored from 0 to 70

Time frame
26 weeks
2

Difference of change in the CDR scale

Difference of change in the CDR scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). CDR scale = Clinical Dementia Rating, scored from 0 to 3

Time frame
26 weeks
3

Difference of change in the ADL scale

Difference of change in the ADL scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). ADL scale = Autonomy scale on daily activities, scored from 0 to 78

Time frame
26 weeks
4

Difference of change in the quality of life scale

Difference of change in the quality of life scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).

Time frame
26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

France Alzheimer

Collaborator

Source ClinicalTrials.gov
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