ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00276510
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Ipsen

Brief Summary:
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 or disease Intervention/treatment Phase
Memory Disorders, Age-Related Retention Disorders, Cognitive Drug: EGb 761® (Tanakan®) Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2002
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Efficacy on rate of cognitive abilities decline [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ]
  2. Effect on concomitant diseases [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ]
  3. Concomitant treatments' reports [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ]
  4. Global evaluation of memory complaint by the patient [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ]
  5. Clinical safety [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ]


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:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00276510


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

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
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Disease
Dementia
Memory Disorders
Alzheimer Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Tauopathies
Neurodegenerative Diseases