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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Cognitive Impairment
Drug: EGb761®
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in brain glucose metabolism measured using 18 FDG-PET [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: October 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EGb 120 mg Drug: EGb761®
Four weeks for AD patients, 18 months for MC and CNE patients
Placebo Comparator: Placebo Drug: Placebo
Placebo 1 tablet BID

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814346

Locations
France
Hôpital Corentin Celton 4 parvis Corentin Celton
Issy-Les-Moulineaux, France
Hôpital de Juvisy
Juvisy sur Orge, France
CMPI "Les Rives de Seine"
Le Vesinet, France
Centre Hospitalier d'Orsay 4 place du Général Leclerc
Orsay, France
Hôpital Broca 54-56 rue Pascal
Paris, France, 75013
Observatoire de l'âge
Paris, France
Private practice
Paris, France, 75009
Hôpital Paul Brousse 12 av Paul-Vaillant-Couturier
Villejuif, France
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Hélène Mathiex-Fortunet, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00814346     History of Changes
Other Study ID Numbers: 2-39-00240-134, 2007-005377-63
Study First Received: December 23, 2008
Last Updated: February 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ipsen:
Mild Alzheimer's disease (AD) patients
Memory complaint patients with cognitive impairment (MC)
Memory complaint patients cognitively normal (CNE)

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014