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

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.
ClinicalTrials.gov Identifier: NCT00500500
Recruitment Status : Terminated (Inability to recruit sufficient number of patients)
First Posted : July 12, 2007
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer Disease Drug: EGb 761® (Tanakan®) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Study Start Date : July 2005
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EGb 761® (Tanakan®)
EGb 761® (Tanakan®)
Drug: EGb 761® (Tanakan®)
Placebo Comparator: Placebo
Drug: EGb 761® (Tanakan®)

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Hôpital La Timone
Marseille, France, 13 005
Sponsors and Collaborators
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 Posted: July 12, 2007    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013

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