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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EGb 120 mg

Group Type ACTIVE_COMPARATOR

EGb761®

Intervention Type DRUG

Four weeks for AD patients, 18 months for MC and CNE patients

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet BID

Interventions

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EGb761®

Four weeks for AD patients, 18 months for MC and CNE patients

Intervention Type DRUG

Placebo

Placebo 1 tablet BID

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No