Status:
COMPLETED
Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions
Lead Sponsor:
Ipsen
Conditions:
Alzheimer's Disease
Cognitive Impairment
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD),...
Eligibility Criteria
Inclusion
- Group Specific
- Cognitively normal elderly (CNE)
- Spontaneous memory complaint by patient,
- Mini-Mental State Exam score ≥ 28.
- Clinical Dementia Rating = 0.
- No Diagnostic And Statistical Manual Of Mental Disorders, Fourth Edition (DSMIV) criteria for Dementia.
- Memory complaints (MC) :
- Spontaneous memory complaint by patient
- Mini-Mental State Exam score ≥ 25
- Clinical Dementia Rating 0.5.
- No DSMIV criteria for Dementia.
- Mild Alzheimer's Disease (AD):
- Mini Mental Status Examination (MMSE) between 20 and 28 (inclusive).
- Clinical Dementia Rating ≥ 1.0
- DSMIV criteria for Dementia.
- National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer's Disease and Related Disorders Association(NINCDS/ADRDA) criteria for probable AD.
- Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantine.
- ≥ 65 years of age, both sex
- Geriatric Depression Scale (GDS) \< 15
- Informed consent signed by the patient or, if necessary by legal representative
Exclusion
- Contraindication to Magnetic Resonance Imaging (MRI) and/or Positron-Emission Tomography (PET) scan
- Forbidden Concomitant medications (Cholinesterase inhibitors and memantine, Specific psychoactive medications,e.g., neuroleptics, chronic anxiolytics including meprobamate, or sedative hypnotics other than benzodiazepines, Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Drugs acting on cerebral nervous system, Antidiabetes medications , Antioxidants medications, Medications known to interfere with cognitive evaluations
- Significant neurological disease and psychiatric disorders/psychotic feature
- Significant medical illness
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00814346
Start Date
October 1 2008
End Date
July 1 2012
Last Update
February 8 2019
Active Locations (8)
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1
Hôpital Corentin Celton 4 parvis Corentin Celton
Issy-les-Moulineaux, France
2
Hôpital de Juvisy
Juvisy-sur-Orge, France
3
CMPI "Les Rives de Seine"
Le Vésinet, France
4
Centre Hospitalier d'Orsay 4 place du Général Leclerc
Orsay, France