Multimodal Preventive Trial for Alzheimer's Disease: MIND-ADmini Pilot Trial Study Design and Progress.
Alzheimer’s disease
Dementia
intervention
lifestyle
multimodal
prevention
randomized controlled trial
Journal
The journal of prevention of Alzheimer's disease
ISSN: 2426-0266
Titre abrégé: J Prev Alzheimers Dis
Pays: Switzerland
ID NLM: 101638820
Informations de publication
Date de publication:
2022
2022
Historique:
entrez:
31
1
2022
pubmed:
1
2
2022
medline:
3
5
2022
Statut:
ppublish
Résumé
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. To evaluate the feasibility of an adapted FINGER-based multimodal lifestyle intervention, with or without medical food, among individuals with prodromal AD. 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. 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. 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).
Sections du résumé
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).
Identifiants
pubmed: 35098971
doi: 10.14283/jpad.2022.4
pmc: PMC8783958
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
30-39Déclaration de conflit d'intérêts
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.
Références
Lancet. 2015 Jun 6;385(9984):2255-63
pubmed: 25771249
Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9
pubmed: 9236950
J Health Soc Behav. 1983 Dec;24(4):385-96
pubmed: 6668417
Health Econ. 1993 Oct;2(3):217-27
pubmed: 8275167
Lancet. 2020 Aug 8;396(10248):413-446
pubmed: 32738937
Psychopharmacol Bull. 1988;24(4):709-11
pubmed: 3249773
Alzheimers Res Ther. 2021 Mar 25;13(1):64
pubmed: 33766132
Pilot Feasibility Stud. 2016 May 20;2:25
pubmed: 27965844
Alzheimers Dement. 2018 Apr;14(4):535-562
pubmed: 29653606
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
J Intern Med. 2014 Mar;275(3):229-50
pubmed: 24605807
Lancet Neurol. 2018 Jan;17(1):27
pubmed: 29263003
Biochem Pharmacol. 2020 Mar;173:113649
pubmed: 31586588
Neuroepidemiology. 2013;41(3-4):198-207
pubmed: 24135720
Lancet Neurol. 2017 May;16(5):338-339
pubmed: 28359750
Psychopharmacol Bull. 1988;24(4):637-9
pubmed: 3249765
Eur Heart J. 2016 Aug 1;37(29):2315-2381
pubmed: 27222591
J Alzheimers Dis. 2018;64(1):71-78
pubmed: 29865075
Am J Clin Nutr. 1999 May;69(5):842-56
pubmed: 10232622
Lancet Neurol. 2007 Aug;6(8):734-46
pubmed: 17616482
Int J Cardiol. 2013 Sep 1;167(5):2102-7
pubmed: 22704872
Neurotherapeutics. 2015 Jan;12(1):66-80
pubmed: 25534394
J Nutr. 2013 Sep;143(9):1414-20
pubmed: 23884386
Alzheimers Dement. 2020 Jul;16(7):1078-1094
pubmed: 32627328
Ann Neurol. 2019 Jan;85(1):114-124
pubmed: 30421454
Eur J Appl Physiol Occup Physiol. 1987;56(6):679-85
pubmed: 3678222
Lancet. 2016 Aug 20;388(10046):738-40
pubmed: 27475274
J Gerontol. 1994 Mar;49(2):M85-94
pubmed: 8126356
Lancet Neurol. 2014 Jun;13(6):614-29
pubmed: 24849862
Lancet Neurol. 2017 Dec;16(12):965-975
pubmed: 29097166
Alzheimers Dement. 2021 Jan;17(1):29-40
pubmed: 32920957
Lancet Neurol. 2006 Sep;5(9):735-41
pubmed: 16914401
Lancet Neurol. 2017 May;16(5):377-389
pubmed: 28359749
Lancet. 2016 Aug 20;388(10046):797-805
pubmed: 27474376
Nat Rev Neurol. 2018 Nov;14(11):653-666
pubmed: 30291317
BMC Geriatr. 2018 Sep 3;18(1):202
pubmed: 30176796
Med Sci Sports Exerc. 2007 Aug;39(8):1435-45
pubmed: 17762378