CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
EGb761® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00814346
NCT00814346Phase 2Completed

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

Ipsen·interventional·Posted Dec 24, 2008·Updated Feb 8, 2019

In Brief

A Phase 2 clinical trial evaluating EGb761® and Placebo for Alzheimer's Disease and Cognitive Impairment. Completed, enrolled 49 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.5 years ago

Interventions

EGb761®drug

Four weeks for AD patients, 18 months for MC and CNE patients

Placebodrug

Placebo 1 tablet BID