1. Integrating a multimodal lifestyle intervention with medical food in prodromal Alzheimer’s disease : the MIND-ADmini randomized controlled trial
- Author
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Thunborg, Charlotta, Wang, Rui, Rosenberg, Anna, Sindi, Shireen, Andersen, Pia, Andrieu, Sandrine, Broersen, Laus M., Coley, Nicola, Couderc, Celine, Duval, Celine Z., Faxen-Irving, Gerd, Hagman, Göran, Hallikainen, Merja, Håkansson, Krister, Kekkonen, Eija, Lehtisalo, Jenni, Levak, Nicholas, Mangialasche, Francesca, Pantel, Johannes, Rydström, Anders, Stigsdotter Neely, Anna, Wimo, Anders, Ngandu, Tiia, Soininen, Hilkka, Hartmann, Tobias, Solomon, Alina, Kivipelto, Miia, Thunborg, Charlotta, Wang, Rui, Rosenberg, Anna, Sindi, Shireen, Andersen, Pia, Andrieu, Sandrine, Broersen, Laus M., Coley, Nicola, Couderc, Celine, Duval, Celine Z., Faxen-Irving, Gerd, Hagman, Göran, Hallikainen, Merja, Håkansson, Krister, Kekkonen, Eija, Lehtisalo, Jenni, Levak, Nicholas, Mangialasche, Francesca, Pantel, Johannes, Rydström, Anders, Stigsdotter Neely, Anna, Wimo, Anders, Ngandu, Tiia, Soininen, Hilkka, Hartmann, Tobias, Solomon, Alina, and Kivipelto, Miia
- Abstract
Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) showed cognitive benefits from a multidomain lifestyle intervention in at-risk older people. The LipiDiDiet trial highlighted benefits of medical food in prodromal Alzheimer’s disease (AD). However, the feasibility and impact of multimodal interventions combining lifestyle with medical food in prodromal AD is unclear. Methods: MIND-ADmini was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomized controlled trial (RCT). Participants were 60–85 years old, had prodromal AD (International Working Group-1 criteria), and vascular/lifestyle risk factors. The parallel-group RCT had three arms: multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multimodal lifestyle intervention + medical food (Fortasyn Connect); and regular health advice/care (control). Participants were randomized 1:1:1 (computer-generated allocation at each site). Outcome evaluators were blinded to randomization. Primary outcome was feasibility of the multimodal intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥ 40% of sessions/domain in ≥ 2/4 domains (lifestyle intervention), and consuming ≥ 60% of the medical food (lifestyle intervention + medical food). The secondary outcomes included adherence/participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive assessments were included as exploratory outcomes, e.g. Clinical Dementia Rating scale. Results: During September 2017-May 2019, 93 individuals were randomized (32 lifestyle intervention, 31 lifestyle + medical food, and 30 control group). Overall recruitment rate was
- Published
- 2024
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