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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:
ClinicalTrials.gov Identifier:
NCT00500500
First Posted: July 12, 2007
Last Update Posted: October 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500500


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

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00500500     History of Changes
Other Study ID Numbers: 2-29-00240-127
First Submitted: July 11, 2007
First Posted: July 12, 2007
Last Update Posted: October 11, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders