Multimodal Preventive Trial for Alzheimer\u2019s Disease: MIND-ADmini Pilot Trial Study Design and Progress

Shireen Sindi ,Anna Rosenberg ,Krister Håkansson ,Eija Kekkonen ,Jenni Lehtisalo ,Francesca Mangialasche ,Christophe Couderc ,Céline Duval ,Sandrine Andrieu ,Johannes Pantel ,Nicola Coley ,Nicholas Levak ,Tobias Hartmann ,Alina Solomon ,Anders Rydström ,Merja Hallikainen ,Pia Andersen ,Gerd Faxén‐Irving ,Charlotta Thunborg ,Laus M Broersen ,Hilkka Soininen ,Göran Hagman ,Tiia Ngandu ,Anders Wimo ,Anna Stigsdotter-Neely ,Miia Kivipelto

doi:10.14283/jpad.2022.4

Abstract

BackgroundInterventions simultaneously targeting multiple risk factors and mechanisms are most likely to be effective in preventing cognitive impairment. This was indicated in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) testing a multidomain lifestyle intervention among at-risk individuals. The importance of medical food at the early symptomatic disease stage, prodromal Alzheimer’s disease (AD), was emphasized in the LipiDiDiet trial. The feasibility and effects of multimodal interventions in prodromal AD are unclear.ObjectivesTo evaluate the feasibility of an adapted FINGER-based multimodal lifestyle intervention, with or without medical food, among individuals with prodromal AD.MethodsMIND-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 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.ResultsScreening began on 28 September 2017 and was completed on 21 May 2019. Altogether 93 participants were randomized and enrolled. The intervention proceeded as planned.ConclusionsFor 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).

Highlights

Curative or disease modifying treatments for dementia and Alzheimer’s disease (AD) are currently not widely available, and prevention has been identified as a global priority
The MIND-ADmini trial investigates whether a multimodal lifestyle-based intervention is feasible among individuals with prodromal AD in four European countries [12]
Finding effective and feasible prevention strategies is important for individuals with prodromal AD who currently lack effective treatments

Summary

Introduction

Curative or disease modifying treatments for dementia and Alzheimer’s disease (AD) are currently not widely available, and prevention has been identified as a global priority. Estimates have shown that at least 40% of dementia cases are attributable to modifiable vascular and lifestyle-related risk factors (e.g. hypertension, diabetes mellitus, smoking, obesity, physical inactivity, depression, low education), creating a clear window of opportunity for prevention [1]. CONCLUSIONS: 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)

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