Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease

Alzheimer Disease Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00500500
• Other study ID #: 2-29-00240-127
• Status: Terminated
• Phase: Phase 2
• Start date: July 2005
• Est. completion date: April 2008

Study information

• Verified date: October 2013
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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….)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• EGb 761® (Tanakan®)

Locations

Country	Name	City	State
France	Hôpital La Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.		Every visit
Secondary	Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day		Every visit