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

NCT00814346 | Completed Phase 2 Results

• 2 other identifiers: 2-39-00240-1342007-005377-63
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Alzheimer's Disease; Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)

  Following statistical parametric mapping (SPM) analyses were performed by the Commissariat à l'Energie Atomique (CEA): * The comparison between treatment groups separately for each group of elderly subjects (CNE and MC groups only) * The comparison between the two groups of elderly subjects (CNE and MC groups only) by treatment group FDG PET demonstrates reductions in the cerebral glucose metabolism that may occur a few years before the overt clinical manifestation of disease. SUVBSA2 = \[Brain radioactivity (Bq/cc)\] / \[Injected dose (MBq)/BSA2\] x \[Blood glucose (g/l)\] BSA2(m\^2) = 0.007184 x Height (cm)\^0.35 x weight (kg)\^0.80 Standardized Uptake Value (SUV) Body Surface Area (BSA)

  From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase

Secondary Outcomes (27)

• Change in Brain Glucose Metabolism in the MC and CNE Groups

  From Baseline (Month 0) to Month 18

• Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups

  From Baseline (Month 0) to Month 9

• Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups

  From Baseline (Month 0) to Month 9

• Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups

  From Baseline (Month 0) to Month 9

• Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups

  From Baseline (Month 0) to Month 9

Study Arms (2)

EGb 120 mg

ACTIVE COMPARATOR

Drug: EGb761®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EGb761® DRUG

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

EGb 120 mg

Placebo DRUG

Placebo 1 tablet BID

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (8)

Hôpital Corentin Celton 4 parvis Corentin Celton

Issy-les-Moulineaux, France

Location

Hôpital de Juvisy

Juvisy-sur-Orge, France

Location

CMPI "Les Rives de Seine"

Le Vésinet, France

Location

Centre Hospitalier d'Orsay 4 place du Général Leclerc

Orsay, France

Location

Private practice

Paris, 75009, France

Location

Hôpital Broca 54-56 rue Pascal

Paris, 75013, France

Location

Observatoire de l'âge

Paris, France

Location

Hôpital Paul Brousse 12 av Paul-Vaillant-Couturier

Villejuif, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Medical Director, Neurology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 8, 2019
• Results First Posted: March 28, 2016

Record last verified: 2019-01

Locations

FR (8)