Trial record 1 of 1 for:    NCT00276510
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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

January 12, 2006
December 14, 2009
February 2002
November 2009   (final data collection date for primary outcome measure)
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 ]
EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis
Complete list of historical versions of study NCT00276510 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Scoring at all available visits will be taken into account:
  • *Efficacy on rate of cognitive and abilities decline
  • *Effect on concomitant diseases
  • *Concomitant treatments' reports
  • *Global evaluation of memory complaint by the patient
  • *Clinical safety
Not Provided
Not Provided
 
A Study of EGb 761® (Tanakan®) in Dementia of Alzheimer Type Onset in Patients Suffering From Memory Complaints
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Memory Disorders, Age-Related
  • Retention Disorders, Cognitive
  • Drug: EGb 761® (Tanakan®)
    120 mg, 1 tablet twice a day, oral route, during 5 years.
  • Other: Placebo
    1 tablet twice a day, oral route, during 5 years.
  • Experimental: 1
    Intervention: Drug: EGb 761® (Tanakan®)
  • Placebo Comparator: 2
    Intervention: Other: Placebo
Vellas B, Coley N, Ousset PJ, Berrut G, Dartigues JF, Dubois B, Grandjean H, Pasquier F, Piette F, Robert P, Touchon J, Garnier P, Mathiex-Fortunet H, Andrieu S; GuidAge Study Group. Long-term use of standardised ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. Lancet Neurol. 2012 Oct;11(10):851-9. doi: 10.1016/S1474-4422(12)70206-5. Epub 2012 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2878
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00276510
2-31-00240-011
Not Provided
Pr B Vellas, Hospital La Grave Casselardit 170 av de Casselardit 31300 Toulouse
Ipsen
Not Provided
Study Director: Phillippe Garnier, MD Ipsen
Ipsen
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP