Randomized controlled trial on the efficacy of a multilevel non-pharmacologic intervention in older adults with subjective memory decline: design and baseline findings of the E.Mu.N.I. study.

Davide Violi, Enrica Cavedo, Chiara Cerami, Giovanni B Frisoni, Harald Hampel, Andrea Falini, Alessandra Marcone, Sandro Iannaccone, Nicola Canessa, Elena Rolandi, Roberto Gasparotti, Claudia Ambrosi, Giulio Munaretto, Federica Ribaldi, Sara Mandelli, Clarissa Ferrari, Samantha Galluzzi, Alessandra Dodich

Journal: Aging clinical and experimental research 2020;32(5):817-826

PMID: 31749018

Full Text on Springer View on PubMed

Abstract

BACKGROUND

Alzheimer's Disease (AD) is a multifactorial disorder driven by genetic and modifiable lifestyle risk factors. Lifestyle primary prevention initiatives may reduce the prevalence and incidence of dementia in older adults.

OBJECTIVES

The E.Mu.N.I study is a randomized controlled trial investigating the effect of multilevel non-pharmacologic interventions on cognitive performances (primary outcome) and structural and vascular brain MRI markers (secondary outcome), as well as markers of brain functional connectivity change (exploratory outcome), in older adults with subjective memory decline (SMD). Here, we present the study design and the baseline features of the sample.

METHODS

Cognitively intact older adults with SMD, enrolled between February 2016 and June 2017, were randomly assigned to one of the 3 interventions for 1 year: Active Control Intervention (ACI), i.e., educational lessons; Partial Intervention (PI), i.e., homotaurine administration (100 mg/die) and lessons on the Mediterranean diet; Multilevel Intervention (MI), i.e., PI plus computerized cognitive training and physical exercise training.

RESULTS

One-hundred and twenty-eight eligible participants were enrolled (66% female; age: 68 ± 5 years). Eighty-two percent of the sample was composed of volunteers with SMD from the community. Participants were randomly allocated to the interventions as follows: ACI (N = 40), PI (N = 44), MI (N = 44). No significant differences among groups emerged on socio-demographic, clinical-neuropsychological variables and MRI markers at baseline.

CONCLUSIONS

The outcomes obtained from the E.Mu.N.I. study will clarify the efficacy of multilevel non-pharmacologic interventions on cognitive and neuroimaging markers in SMD individuals. This is a crucial step forward for the development of cost-effective non-pharmacologic primary prevention initiatives for AD.

Address: Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.; NIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.; Statistics Service, IRCCS Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.; Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.; Memory Clinic and LANVIE-Laboratory of Neuroimaging of Ageing, University Hospitals and University of Geneva, Geneva, Switzerland.; Department of Life Sciences, University of Trieste, Trieste, Italy.; Department of Diagnostic Imaging, Neuroradiology Unit, University of Brescia, Brescia, Italy.; Millennium Sport and Fitness, 25124, Brescia, Italy.; NEtS Center, Scuola Universitaria Superiore IUSS Pavia, 27100, Pavia, Italy.; Cognitive Neuroscience Laboratory, IRCCS ICS Maugeri, 27100, Pavia, Italy.; Department of Clinical Neuroscience, San Raffaele Turro Hospital, 20132, Milan, Italy.; Division of Neuroscience, Department of Neuroradiology and CERMAC, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.; Alzheimer Precision Medicine (APM), Établissements Publics à Caractère Scientifique et Technologique (E.P.S.T.), AP-HP, Pitié-Salpêtrière Hospital, Sorbonne University Clinical Research Group (GRC n°21), Boulevard de l'hôpital, 75013, Paris, France.; Brain and Spine Institute (ICM), INSERM U 1127, CNRS UMR 7225, Boulevard de l'hôpital, 75013, Paris, France.; Department of Neurology, Pitié-Salpêtrière Hospital, AP-HP, Institute of Memory and Alzheimer's Disease (IM2A), François Lhermitte Building, 47 Boulevard de l'hôpital, 75013, Paris Cedex 13, France.; Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. [email protected].; Alzheimer Precision Medicine (APM), Établissements Publics à Caractère Scientifique et Technologique (E.P.S.T.), AP-HP, Pitié-Salpêtrière Hospital, Sorbonne University Clinical Research Group (GRC n°21), Boulevard de l'hôpital, 75013, Paris, France. [email protected].; Brain and Spine Institute (ICM), INSERM U 1127, CNRS UMR 7225, Boulevard de l'hôpital, 75013, Paris, France. [email protected].; Department of Neurology, Pitié-Salpêtrière Hospital, AP-HP, Institute of Memory and Alzheimer's Disease (IM2A), François Lhermitte Building, 47 Boulevard de l'hôpital, 75013, Paris Cedex 13, France. [email protected].

DOI: 10.1007/s40520-019-01403-3