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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00276510

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 IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Secondary Outcome Measures:

Efficacy on rate of cognitive and abilities decline [ Time Frame: Baseline, month 12, 24, 36, 48 and 60 ]
Effect on concomitant diseases [ Time Frame: All available visits ]
Concomitant treatments' reports [ Time Frame: All available visits ]
Global evaluation of memory complaint by the patient [ Time Frame: All available visits ]
Clinical safety [ Time Frame: All available visits ]

Enrollment:	2878
Study Start Date:	February 2002
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental	Drug: EGb 761® (Tanakan®) 120 mg, 1 tablet twice a day, oral route, during 5 years.
2: Placebo Comparator	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 665 Study Locations

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Mehemed Ouzid, MD

Ipsen

More Information

Study ID Numbers:	2-31-00240-011
Study First Received:	January 12, 2006
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00276510
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Alzheimer Disease
Central Nervous System Diseases
Urinary Retention
Brain Diseases
Neurodegenerative Diseases
Memory Disorders
Cognition Disorders

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Neurobehavioral Manifestations
Delirium

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009