Alzheimer's Disease
Conditions
Keywords
sleep, Alzheimer, old patients
Brief summary
The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.
Detailed description
Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.
Interventions
DRUGGalantamine and Donepezil
the analysis of two inhibitors of Ach-E : galantamine and donézepil in over 65 years old patients suffering from Alzheimer's disease (MMSE between 20 and 26) without Alzheimer's medication
Sponsors
Janssen-Cilag Farmaceutica Ltda.
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 and over years old * Patients suffering from Alzheimer disease * Patient living with someone at home * Written consent given
Exclusion criteria
* Galantamine or Donepezil hypersensibility * Patient living alone and in a medicalized structure * Concomitant medication * Chronical diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil | administration of galantamine or donépézil |
Secondary
| Measure | Time frame |
|---|---|
| Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep | during the iatrogenic modifications |
Countries
France
Outcome results
None listed