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Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With: Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00814346
First received: December 23, 2008
Last updated: February 26, 2013
Last verified: February 2013

December 23, 2008
February 26, 2013
October 2008
July 2012   (final data collection date for primary outcome measure)
Change in brain glucose metabolism measured using 18 FDG-PET [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00814346 on ClinicalTrials.gov Archive Site
  • Change in cognitive tests in MC and CNE groups [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in cognitive tests in MC and CNE groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in brain glucose metabolism in the MC and CNE groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in brain atrophy in the MC and CNE groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With: Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal
Effect of Oral EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal Elderly. Phase II, Randomised, Double-blind, Parallel Groups, Placebo-controlled Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Cognitive Impairment
  • Drug: EGb761®
    Four weeks for AD patients, 18 months for MC and CNE patients
  • Drug: Placebo
    Placebo 1 tablet BID
  • Active Comparator: EGb 120 mg
    Intervention: Drug: EGb761®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00814346
2-39-00240-134, 2007-005377-63
No
Ipsen
Ipsen
Not Provided
Study Director: Hélène Mathiex-Fortunet, M.D. Ipsen
Ipsen
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP