Memory Disorders, Age-Related, Retention Disorders, Cognitive
Conditions
Brief summary
The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.
Interventions
120 mg, 1 tablet twice a day, oral route, during 5 years.
OTHERPlacebo
1 tablet twice a day, oral route, during 5 years.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spontaneously reporting a memory complaint * Short anxiety battery test \< 6, (only if patient screened at GP site) * Geriatric depression scale \< 15 * Mini-mental state (MMS) \> 25 in GP's office (in hospital site MMS is done as complementary scale)
Exclusion criteria
* Objective memory impairment * Clinician rated dementia staging system \> 0.5 * Mini-mental state \< 25 * Dementia, past history of seizures, Parkinson disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis | Baseline, month 12, 24, 36, 48 and 60 |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy on rate of cognitive abilities decline | Baseline, month 12, 24, 36, 48 and 60 |
| Effect on concomitant diseases | Baseline, month 12, 24, 36, 48 and 60 |
| Concomitant treatments' reports | Baseline, month 12, 24, 36, 48 and 60 |
| Global evaluation of memory complaint by the patient | Baseline, month 12, 24, 36, 48 and 60 |
| Clinical safety | Baseline, month 12, 24, 36, 48 and 60 |
Countries
France
Outcome results
None listed