Effect of EGb 761® on Patients With Mild to Moderate Alzh... | NCT00500500

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

NCT00500500

Sponsor

Ipsen

Status

Terminated

Last Update Posted

Jun 26, 2023Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Alzheimer Disease

Interventions

EGb 761® (Tanakan®)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to recruit sufficient number of patients

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jul 11, 2007

First Submission Date that Met QC Criteria

Jul 11, 2007

First Posted Date

Jul 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2023

Last Update Posted Date

Jun 26, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EGb 761® (Tanakan®)	Experimental	EGb 761® (Tanakan®)	Drug: EGb 761® (Tanakan®)
Placebo	Placebo Comparator	Placebo	Drug: EGb 761® (Tanakan®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EGb 761® (Tanakan®)	Drug		EGb 761® (Tanakan®) Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day		Every visit

Other Outcomes

Not provided

Eligibility Module

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….)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Study Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital La Timone		Marseille		13 005	France

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C063170	Ginkgo biloba extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided