MIND-ADmini is a multinational proof-of-concept 6-month randomized controlled trial (RCT), with four trial sites (Sweden, Finland, Germany, France). The trial targeted individuals with prodromal Alzheimer´s disease (AD) defined using the International Working Group-1 criteria, and with vascular or lifestyle-related risk factors. The parallel-group RCT includes three arms: 1) multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); 2) multimodal lifestyle intervention + medical food (Fortasyn Connect); and 3) regular health advice/ care (control group). Primary outcomes are feasibility and adherence. Secondary outcomes are adherence to the individual intervention domains and healthy lifestyle changes. A total of 93 participants were randomized and enrolled. A 6-month optional extension was conducted at the Swedish site. For the first time, this pilot trial tests the feasibility and adherence to a multimodal lifestyle intervention, alone or combined with medical food, among individuals with prodromal AD. It can serve as a model for combination therapy trials (non-pharma, nutrition-based and/or pharmacological interventions). MIND-ADmini is part of the World-Wide FINGERS global network of multidomain RCTs for risk reduction and prevention of dementia and Alzheimer's disease (https://fbhi.se/world-wide-fingers-network/).
Please read more in the following open-access journal article: https://link.springer.com/article/10.14283/jpad.2022.4
ClinicalTrials.gov identifier NCT03249688
Manuscripts citing this dataset
- https://link.springer.com/article/10.14283/jpad.2022.4
Data access can be requested via AD Workbench FAIR portal here. Access requests are reviewed and, upon approval, data are queried remotely and accessed via the FDSA.
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