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Multimodal Preventive Trial for Alzheimer’s Disease: MIND-ADmini Pilot Trial Study Design and Progress
Karolinska Institutet ; Imperial College, GBR.
Karolinska Institutet ; Karolinska University Hospital.
Karolinska Institutet ; University of Eastern Finland, FIN.
Karolinska Institutet ; Karolinska University Hospital.
Vise andre og tillknytning
2022 (engelsk)Inngår i: The Journal of Prevention of Alzheimer's Disease, ISSN 2274-5807, E-ISSN 2426-0266, Vol. 9, nr 1, s. 30-39Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

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).

sted, utgiver, år, opplag, sider
Serdi-Editions , 2022. Vol. 9, nr 1, s. 30-39
Emneord [en]
Alzheimer’s disease, Dementia, intervention, lifestyle, multimodal, prevention, randomized controlled trial, aged, Alzheimer disease, Article, cardiometabolic risk, cognitive therapy, cohort analysis, controlled study, exercise, feasibility study, female, Finland, France, Germany, healthy lifestyle, human, lifestyle modification, major clinical study, male, multicenter study, nutritional support, outcome assessment, parallel design, patient compliance, patient counseling, pilot study, prevention study, prodromal symptom, proof of concept, prophylaxis, risk factor, risk management, Sweden
HSV kategori
Forskningsprogram
Psykologi inr. medicinsk psykologi
Identifikatorer
URN: urn:nbn:se:kau:diva-89076DOI: 10.14283/jpad.2022.4ISI: 000745744400001Scopus ID: 2-s2.0-85123467662OAI: oai:DiVA.org:kau-89076DiVA, id: diva2:1643567
Tilgjengelig fra: 2022-03-10 Laget: 2022-03-10 Sist oppdatert: 2024-01-08bibliografisk kontrollert

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