A randomized, open-label clinical trial in mild cognitive impairment with EGb 761 examining blood markers of inflammation and oxidative stress

Study design

The ACE-2020-EGb 761 study is a Phase IV, single-center, randomized, open-label, parallel-group clinical trial (CT) performed at the Ace Alzheimer Center Barcelona. The study consists of a cohort of individuals with MCI (GDS = 3) followed up for 12 months. Later, an extension of the study was approved, allowing for an additional follow-up period of 12 months. The protocol version 2 extension was approved on 31/01/2022.

During the first 12 months of the study, participants were randomly assigned to one of two treatment groups. To achieve allocation concealment, randomization was independently conducted online using a web-based application. The randomization was balanced and non-stratified. In the first arm, MCI patients were treated with 1 daily tablet of EGb 761 240 mg orally (study group, n = 50), and in the second arm, MCI patients with identical clinical…