EMuNI Project: Multiple Nonpharmacological Interventions

NCT03382353 | Completed

• 1 other identifier: GR-2011-02350494
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lifestyle Risk Reduction

Keywords

primary prevention; Subjective Cognitive Decline; Neuroimaging; Alzheimer's disease; nonpharmacological interventions; multidomain lifestyle interventions

Outcome Measures

Primary Outcomes (1)

• Cognitive functions

  Neuropsychological test performances

  12 months

Secondary Outcomes (3)

• Basic imaging marker 1

  12 months

• Basic imaging marker 2

  12 months

• Basic imaging marker 3

  12 months

Other Outcomes (2)

• Advanced imaging marker 1

  12 months

• Advanced imaging marker 2

  12 months

Study Arms (3)

No Treatment (NT)

ACTIVE COMPARATOR

Educational training

Behavioral: Educational training

Partial Treatment (PT)

EXPERIMENTAL

Nutritional supplementation \& Counselling on a brain-healthy diet

Dietary Supplement: Nutritional supplementation; Behavioral: Counselling on a brain-healthy diet

Full Treatment (FT)

EXPERIMENTAL

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

Interventions

Nutritional supplementation DIETARY_SUPPLEMENT

Daily consumption of Tramiprosate (100 mg) for 1 year

Full Treatment (FT); Partial Treatment (PT)

Educational training BEHAVIORAL

16 educational lessons (twice a week): basic principles of different cognitive domains (e.g. memory, attention, perception) and educational DVD viewing.

No Treatment (NT)

Counselling on a brain-healthy diet BEHAVIORAL

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.

Full Treatment (FT); Partial Treatment (PT)

Physical exercise training BEHAVIORAL

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

Full Treatment (FT)

Computerized cognitive training BEHAVIORAL

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).

Full Treatment (FT)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 60 and 80 years;
• presence of memory complaints

You may not qualify if:

• objective cognitive impairment on standard neuropsychological testing;
• history of psychiatric disorders or current clinically relevant depressive or anxious symptoms;
• pacemakers, cochlear implant, metal inserts in the head or shoulders

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• Ospedale San Raffaele: collaborator
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Study Sites (2)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (7)

• Bowman GL, Silbert LC, Howieson D, Dodge HH, Traber MG, Frei B, Kaye JA, Shannon J, Quinn JF. Nutrient biomarker patterns, cognitive function, and MRI measures of brain aging. Neurology. 2012 Jan 24;78(4):241-9. doi: 10.1212/WNL.0b013e3182436598. Epub 2011 Dec 28.

  PMID: 22205763 BACKGROUND

• Cavedo E, Galluzzi S, Pievani M, Boccardi M, Frisoni GB. Norms for imaging markers of brain reserve. J Alzheimers Dis. 2012;31(3):623-33. doi: 10.3233/JAD-2012-111817.

  PMID: 22672878 BACKGROUND

• Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.

  PMID: 21282661 BACKGROUND

• Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

  PMID: 25405755 BACKGROUND

• Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21.

  PMID: 21514248 BACKGROUND

• Vemuri P, Lesnick TG, Przybelski SA, Knopman DS, Roberts RO, Lowe VJ, Kantarci K, Senjem ML, Gunter JL, Boeve BF, Petersen RC, Jack CR Jr. Effect of lifestyle activities on Alzheimer disease biomarkers and cognition. Ann Neurol. 2012 Nov;72(5):730-8. doi: 10.1002/ana.23665.

  PMID: 23280791 BACKGROUND

• Rolandi E, Dodich A, Mandelli S, Canessa N, Ferrari C, Ribaldi F, Munaretto G, Ambrosi C, Gasparotti R, Violi D, Iannaccone S, Marcone A, Falini A, Frisoni GB, Galluzzi S, Cerami C, Cavedo E. Targeting brain health in subjective cognitive decline: insights from a multidomain randomized controlled trial. Aging Clin Exp Res. 2025 May 14;37(1):151. doi: 10.1007/s40520-025-03062-z.

  PMID: 40366507 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior; Alzheimer Disease

Interventions

Dietary Supplements; Training Support; Exercise

Condition Hierarchy (Ancestors)

Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Financial Support; Economics; Health Care Economics and Organizations; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Enrica Cavedo, PhD

  IRCCS Centro San Giovanni di Dio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: December 22, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

IT (2)