Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease
Phase 2
Terminated
- Conditions
- Alzheimer Disease
- Interventions
- Drug: EGb 761® (Tanakan®)
- Registration Number
- NCT00500500
- Lead Sponsor
- Ipsen
- Brief Summary
The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- female or male of 50 to 85 years old with a care giver
- Mini Mental Status (MMS) test between 16 to 26 inclusive
- Clinical Dementia Rating (CDR) test inferior or equal to 1
- National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia
Exclusion Criteria
- patient already treated by medicines which could interfere with the study
- low level of vitamin B12 and folate which are considered as clinically relevant
- clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness....)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EGb 761® (Tanakan®) EGb 761® (Tanakan®) EGb 761® (Tanakan®) Placebo EGb 761® (Tanakan®) Placebo
- Primary Outcome Measures
Name Time Method Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets. Every visit
- Secondary Outcome Measures
Name Time Method Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day Every visit
Trial Locations
- Locations (1)
Hôpital La Timone
🇫🇷Marseille, France