NCT00814346

Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions

Effect of Oral EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal Elderly. Phase II, Randomised, Double-blind, Parallel Groups, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.

Conditions

• Alzheimer's Disease
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	EGb761®	Four weeks for AD patients, 18 months for MC and CNE patients
DRUG	Placebo	Placebo 1 tablet BID

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2008-12-24
• Last updated: 2019-02-08
• Results posted: 2016-03-28

Locations

8 sites across 1 country: France