Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions

Ipsen

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Cognitive Impairment

Treatments

Drug: Placebo

Drug: EGb761®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00814346

2-39-00240-134

2007-005377-63 (EudraCT Number)

Details and patient eligibility

About

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), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.

Enrollment

49 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Group Specific Inclusion Criteria:

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 criteria

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