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

June 23, 2023 updated by: Ipsen

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13 005
        • Hôpital La Timone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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….)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: EGb 761® (Tanakan®)
Experimental: EGb 761® (Tanakan®)
Drug: EGb 761® (Tanakan®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
Time Frame: Every visit
Every visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Every visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Study Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimated)

July 12, 2007

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-29-00240-127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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