Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease

This study has been terminated.
(Inability to recruit sufficient number of patients)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00500500
First received: July 11, 2007
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: EGb 761® (Tanakan®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets. [ Time Frame: Every visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day [ Time Frame: Every visit ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGb 761® (Tanakan®)
EGb 761® (Tanakan®)
Drug: EGb 761® (Tanakan®)
Placebo Comparator: Placebo
Placebo
Drug: EGb 761® (Tanakan®)

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female or male of 50 to 85 years old with a care giver
  • Mini Mental Status (MMS) test between 16 to 26 inclusive
  • Clinical Dementia Rating (CDR) test inferior or equal to 1
  • National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
  • Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia

Exclusion Criteria:

  • patient already treated by medicines which could interfere with the study
  • low level of vitamin B12 and folate which are considered as clinically relevant
  • clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness….)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500500

Locations
France
Hôpital La Timone
Marseille, France, 13 005
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00500500     History of Changes
Other Study ID Numbers: 2-29-00240-127
Study First Received: July 11, 2007
Last Updated: October 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
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 April 22, 2014