Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions
Condition: Alzheimer's Disease; Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: EGb761®; Placebo
Intervention description: Four weeks for AD patients, 18 months for MC and CNE patients; Placebo 1 tablet BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Mild Alzheimer's disease (AD) patients; Memory complaint patients with cognitive impairment (MC); Memory complaint patients cognitively normal (CNE)

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), 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.
    

Eligibility criteria:

        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