An interventional study of Nutritional supplementation and Educational training in Lifestyle Risk Reduction, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Completed at 2 sites in Italy. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Treatment
By 2030, the global prevalence of Alzheimer's Disease (AD) is predicted to reach 65.7 million worldwide. Despite extensive research efforts, a cure for AD has not been identified. Recent studies on non-demented individuals have demonstrated the importance of a healthy lifestyle (physical exercise, healthy diet) and non pharmacological interventions (diet supplements) to delay the onset of the cognitive decline (Vemuri P et al., 2012). Given that AD is a multi-factorial disorder, some multi- component interventions at early stages could be the best strategy currently available to delay the AD onset. The aim of this study is to investigate the effects of combined non-pharmacological interventions, at different levels of intensity, on cognitive performance, on basic (hippocampal, brain ventricle volumes and white matter lesions) and advanced magnetic resonance imaging (MRI) markers (Resting-state Functional MRI, Probabilistic Diffusion Tensor Tractography
BACKGROUND Recent evidence showed that aerobic exercise, dietary habits and nutritional supplements consumption seem essential for maintaining good cognitive performances increasing hippocampal volume (HV) in healthy elderly people (Erickson et al., 2011; Bowman et al., 2012). Computerized cognitive trainings are effective in improving cognitive functions of healthy older adults (Lampit et al., 2014). Subjective memory complaint (SMC) individuals showed HV, white matter lesions (WML) and brain ventricle volumes (BVV) at limits of normative population (Cavedo et al., 2012) supporting the hypothesis that they are persons at risk of AD (Sperling et al., 2011). The above non-pharmacological treatments, when separately applied, do not impact on cognition and neuropathological processes of AD. On the contrary, combined treatments, in persons at risk to develop AD, could represent the first line of intervention to delay the onset of cognitive impairment.
SPECIFIC AIMS
HYPHOTESIS AND SIGNIFICANCE An improvement in cognitive performances, basic (HV, WML, BVV) and advanced (structural brain connectivity and brain resting networks) MRI markers will be expected in FT group compared to NT group. Moreover, the investigators hypothesize an effect dependent of the number of combined treatments, thus the PT group is expected to show intermediate results (among NT and FT groups) in the cognitive performances, basic and advanced MRI markers previously described.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's enrollment of 120 is below the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
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Clinically significant
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Educational training
Behavioral: Educational training
Nutritional supplementation \& Counselling on a brain-healthy diet
Dietary Supplement: Nutritional supplementation · Behavioral: Counselling on a brain-healthy diet
Nutritional supplementation \& Counselling on a brain-healthy diet \& Physical exercise training \& Computerized cognitive training
Dietary Supplement: Nutritional supplementation · Behavioral: Counselling on a brain-healthy diet · Behavioral: Physical exercise training · Behavioral: Computerized cognitive training
Daily consumption of Tramiprosate (100 mg) for 1 year
16 educational lessons (twice a week): basic principles of different cognitive domains (e.g. memory, attention, perception) and educational DVD viewing.
4 lessons on the principles of Mediterranean Diet lead by a nutritionist, aimed to teach how to include brain-healthy foods in daily diet (e.g. antioxidant, omega-3 fatty acids and vitamins). Each participant will receive the educational material presented.
80 sessions of physical exercise supervised by a Fitness Training Expert with the aim of achieving 150 minutes of moderate-intensity physical activity per week
16 cognitive training sessions (twice a week) supervised by a psychologist, aimed to improve Attention, Processing speed, Memory, Social skills and Intelligence using BrainHQ (www.brainhq.com).
Cognitive functions
Neuropsychological test performances
Time frame: 12 months
Basic imaging marker 1
Hippocampal volumes
Time frame: 12 months
Basic imaging marker 2
White matter hyperintensities volumes
Time frame: 12 months
Basic imaging marker 3
Brain ventricle volumes
Time frame: 12 months
Advanced imaging marker 1
Structural brain connectivity
Time frame: 12 months
Advanced imaging marker 2
Functional networks connectivity at rest
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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IRCCS Centro San Giovanni di Dio Fatebenefratelli