Study design
MCI, GDS
ADVERSE EVENTS, ALZHEIMER
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, ACE-2020-EGb761 Study Flow Chart. The ACE-2020-EGb761 study was initially designed as a Phase IV, single-center, randomized, open-label, parallel-group clinical trial consisting of the 12-month follow-up of a cohort of participants with MCI (version 1). In January 2022, an extension with an additional 12-month follow-up period was approved.At the end of the first year of follow-up (v2), all participants who completed the study were offered the opportunity to continue in an extended phase consisting of an additional year of follow-up. During this extended period, participants in the control group were offered to begin treatment with 1 daily tablet of EGb 761 240 mg orally for 12 months (Fig. The maximum total duration of the study for each participant is 2 years. Participants will have 6 visits: a baseline visit (v0), a follow-up visit at 6 months (v1), a follow-up visit at 12 months (v2), a follow-up visit at 18 months (v3), a follow-up visit at 24 months (v4, final), and a follow-up visit (v5) 1 month after the final visit. The procedures for each visit are completed within a maximum of 30 days.In the study group receiving 1 daily tablet of EGb 761 240 mg orally, the medication was dispensed at the Ace Alzheimer Center Barcelona’s Pharmacy every 3 months, with control of therapeutic compliance, adverse events, and an accounting of the returned medication using an ad hoc questionnaire to monitor treatment adherence. This questionnaire also includes four items with dichotomous response categories with yes or no to assess the compliance.