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

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: EGb 761® (Tanakan®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500500

2-29-00240-127

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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....)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

EGb 761® (Tanakan®)

Experimental group

Description:

EGb 761® (Tanakan®)

Treatment:

Drug: EGb 761® (Tanakan®)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: EGb 761® (Tanakan®)