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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00814346

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) A first phase of four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at M1 using 18 FDG-PET, as primary endpoint 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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: EGb761® Four weeks for AD patients, 18 months for MC and CNE patients
2: Placebo Comparator	Drug: Placebo Placebo 1 tablet BID

Eligibility

Ages Eligible for Study:	70 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.
≥ 70 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, 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

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

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

France
Hôpital Broca 54-56 rue Pascal	Recruiting
Paris, France, 75013
Contact (+33) (0)1 44 08 36 36
Principal Investigator: Anne Sophie Rigaud, MD, PhD

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Cecile Merdrignac

Ipsen

More Information

Responsible Party:	Ipsen ( Cecile Merdrignac )
Study ID Numbers:	2-39-00240-134
Study First Received:	December 23, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00814346
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Ipsen:

Mild Alzheimer's disease (AD) patients
Memory complaint patients with cognitive impairment (MC)
Memory complaint patients cognitively normal (CNE)

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 15, 2009