Back to resultsEffect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
EGb 761® (Tanakan®)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility 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….)
Sites / Locations
- Hôpital La Timone
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EGb 761® (Tanakan®)
Placebo
Arm Description
EGb 761® (Tanakan®)
Placebo
Outcomes
Primary Outcome Measures
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
Secondary Outcome Measures
Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500500
Brief Title
Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit sufficient number of patients
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EGb 761® (Tanakan®)
Arm Type
Experimental
Arm Description
EGb 761® (Tanakan®)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
EGb 761® (Tanakan®)
Primary Outcome Measure Information:
Title
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
Time Frame
Every visit
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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….)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital La Timone
City
Marseille
ZIP/Postal Code
13 005
Country
France
12. IPD Sharing Statement
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Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease
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