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

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.

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500500
Enrollment
40
Registered
2007-07-12
Start date
2005-07-31
Completion date
2008-04-30
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

Sponsors

Ipsen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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….)

Design outcomes

Primary

MeasureTime frame
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.Every visit

Secondary

MeasureTime frame
Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per dayEvery visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026