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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:
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
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, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014