Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022;9(1):30-39.
doi: 10.14283/jpad.2022.4.

Multimodal Preventive Trial for Alzheimer's Disease: MIND-ADmini Pilot Trial Study Design and Progress

S Sindi  1 , C Thunborg, A Rosenberg, P Andersen, S Andrieu, L M Broersen, N Coley, C Couderc, C Z Duval, G Faxen-Irving, G Hagman, M Hallikainen, K Håkansson, J Lehtisalo, N Levak, F Mangialasche, J Pantel, E Kekkonen, A Rydström, A Stigsdotter-Neely, A Wimo, T Ngandu, H Soininen, T Hartmann, A Solomon, M Kivipelto
Affiliations
Randomized Controlled Trial

Multimodal Preventive Trial for Alzheimer's Disease: MIND-ADmini Pilot Trial Study Design and Progress

S Sindi et al. J Prev Alzheimers Dis. 2022.

Abstract

Background: Interventions 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.

Objectives: To evaluate the feasibility of an adapted FINGER-based multimodal lifestyle intervention, with or without medical food, among individuals with prodromal AD.

Methods: 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 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.

Results: Screening began on 28 September 2017 and was completed on 21 May 2019. Altogether 93 participants were randomized and enrolled. The intervention proceeded as planned.

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).

Keywords: Alzheimer’s disease; Dementia; intervention; lifestyle; multimodal; prevention; randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

Dr. Andrieu reports grants from EU – JPND program – MIND-AD project, during the conduct of the study; grants from EU – H2020 program – PRODEMOS project, grants from CNAV, personal fees and non-financial support from Nestlé SA, outside the submitted work. Dr. Broersen is employee of Danone Nutricia Research. Dr. Coley reports grants from Agence Nationale de la Recherche (ANR), during the conduct of the study. Dr. Wimo reports personal fees from Biogen, from Eisai, grants from Merck, outside the submitted work. Dr. Soininen reports grants from Academy of Finland for JNPD EU project, during the conduct of the study; personal fees from Consultation fee, outside the submitted work. Dr. Hartmann reports grants from BMBF-JPND, grants from EU FP7 LipiDiDiet, during the conduct of the study. Dr. Solomon reports grants from European Research Council grant 804371, grants from Alzheimerfonden, grants from Academy of Finland, during the conduct of the study. Dr. Kivipelto reports grants from The EU Joint Programme – Neurodegenerative Disease Research (JPND), Alzheimerfonden, Hjärnfonden, Center for Innovative Medicine (CIMED) at Karolinska Institutet South Campus, Knut and Alice Wallenberg Foundation, Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse, Joint Program of Neurodegenerative Disorders – prevention (EURO-FINGERS), Region Stockholm (ALF, NSV), Stiftelsen Stockholms sjukhem, Swedish Research Council for Health Working Life and Welfare (FORTE), during the conduct of the study; and was an invited speaker and received an honorarium at an industry-led symposium including Biogen, Nutricia and Nestlé, outside the submitted work.

Figures

Figure 1
Figure 1
MIND-ADMINI design
See this image and copyright information in PMC

References

    1. Livingston G, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020;396(10248):413–446. doi: 10.1016/S0140-6736(20)30367-6. - DOI - PMC - PubMed
    1. World Health Organisation. Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. 2019 [cited 2019 20 December]; Available from: https://www.ncbi.nlm.nih.gov/pubmed/31219687. - PubMed
    1. Solomon A, et al. Advances in the prevention of Alzheimer’s disease and dementia. J Intern Med. 2014;275(3):229–50. doi: 10.1111/joim.12178. - DOI - PMC - PubMed
    1. Boyle PA, et al. Attributable risk of Alzheimer’s dementia attributed to age-related neuropathologies. Ann Neurol. 2019;85(1):114–124. doi: 10.1002/ana.25380. - DOI - PMC - PubMed
    1. Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018;14(11):653–666. doi: 10.1038/s41582-018-0070-3. - DOI - PubMed

Publication types