NCT00500500

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 26, 2023

Status Verified

October 1, 2013

Enrollment Period

2.8 years

First QC Date

July 11, 2007

Last Update Submit

June 23, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.

    Every visit

Secondary Outcomes (1)

  • Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day

    Every visit

Study Arms (2)

EGb 761® (Tanakan®)

EXPERIMENTAL

EGb 761® (Tanakan®)

Drug: EGb 761® (Tanakan®)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: EGb 761® (Tanakan®)

Interventions

EGb 761® (Tanakan®)DRUG
EGb 761® (Tanakan®)Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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….)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital La Timone

Marseille, 13 005, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Study Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

July 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 26, 2023

Record last verified: 2013-10

Locations

FR(1)