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A Study of EGb 761® (Tanakan®) in Dementia of Alzheimer Type Onset in Patients Suffering From Memory Complaints

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276510
First received: January 12, 2006
Last updated: December 14, 2009
Last verified: December 2009
History of Changes
  Purpose

The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.


Condition Intervention Phase
Memory Disorders, Age-Related
Retention Disorders, Cognitive
 Drug: EGb 761® (Tanakan®)
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy on rate of cognitive abilities decline [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Effect on concomitant diseases [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Concomitant treatments' reports [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Global evaluation of memory complaint by the patient [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Clinical safety [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: Yes ]

Enrollment: 2878
Study Start Date: February 2002
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: EGb 761® (Tanakan®)
120 mg, 1 tablet twice a day, oral route, during 5 years.
Placebo Comparator: 2 Other: Placebo
1 tablet twice a day, oral route, during 5 years.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spontaneously reporting a memory complaint
  • Short anxiety battery test < 6, (only if patient screened at GP site)
  • Geriatric depression scale < 15
  • Mini-mental state (MMS) > 25 in GP's office (in hospital site MMS is done as complementary scale)

Exclusion Criteria:

  • Objective memory impairment
  • Clinician rated dementia staging system > 0.5
  • Mini-mental state < 25
  • Dementia, past history of seizures, Parkinson disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276510

  Show 700 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Phillippe Garnier, MD Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pr B Vellas, Hospital La Grave Casselardit 170 av de Casselardit 31300 Toulouse
ClinicalTrials.gov Identifier: NCT00276510     History of Changes
Other Study ID Numbers: 2-31-00240-011
Study First Received: January 12, 2006
Last Updated: December 14, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Memory Disorders
Urinary Retention
Stress, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013