Lifestyle Risk ReductionEMuNINCT03382353
EMuNI Project: Multiple Nonpharmacological Interventions
A study testing Nutritional supplementation, Educational training and Counselling on a brain-healthy diet in people with Lifestyle Risk Reduction, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Risk Reduction
- What is being tested?
- Nutritional supplementation, Educational training and Counselling on a brain-healthy diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 60 and 80 years;
- presence of memory complaints
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
Ospedale San Raffaele
Milan, 20132
About this study
Official title: Efficacy of Multiple Nonpharmacological Interventions in Individuals With Subjective Memory Complaints
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
Read the detailed description
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
- To investigate the combined effect of aerobic exercise, dietary habits, nutritional supplements, and cognitive training administered at three different levels of intensity on cognitive performance in subjective memory complaints individuals. The three different intensity levels of nonpharmacological treatments will be organized as follows: (i) No Treatment (NT) will include educational training (sham condition); (ii) Partial Treatment (PT) will include exclusively the consumption of a nutritional supplement and a training for a balanced diet; (iii) Full treatment (FT) will include all above condition plus computerized cognitive training (no sham condition) and aerobic fitness training.
- To investigate the effect of the above treatments (NT, PT, FT) on basic markers of magnetic resonance imaging (MRI) such as HV, WML and Brain Ventricle Volume (BVV) in subjective memory complaints individuals.
- To investigate the effect of NT, PT and FT on advanced MRI markers such as structural brain connectivity and brain resting networks in subjective memory complaints individuals.
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.
- Conditions
- Lifestyle Risk Reduction
- Being tested
- Nutritional supplementation, Educational training, Counselling on a brain-healthy diet, Physical exercise training, Computerized cognitive training
- Keywords
- primary prevention, Subjective Cognitive Decline, Neuroimaging, Alzheimer's disease, nonpharmacological interventions, multidomain lifestyle interventions
- Medical subject headings
- Risk Reduction Behavior, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementationDietary supplement
Daily consumption of Tramiprosate (100 mg) for 1 year
Educational trainingBehavioural
16 educational lessons (twice a week): basic principles of different cognitive domains (e.g. memory, attention, perception) and educational DVD viewing.
Counselling on a brain-healthy dietBehavioural
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.
Physical exercise trainingBehavioural
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
Computerized cognitive trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| No Treatment (NT) | Active comparator | Educational training Receives: Behavioral: Educational training |
| Partial Treatment (PT) | Experimental | Nutritional supplementation \& Counselling on a brain-healthy diet Receives: 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 Receives: Dietary Supplement: Nutritional supplementation; Behavioral: Counselling on a brain-healthy diet; Behavioral: Physical exercise training; Behavioral: Computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions
Neuropsychological test performances
Measured: 12 months
Secondary outcomes (3)
Basic imaging marker 1
Hippocampal volumes
Measured: 12 months
Basic imaging marker 2
White matter hyperintensities volumes
Measured: 12 months
Basic imaging marker 3
Brain ventricle volumes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lifestyle Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele, Istituto Di Ricerche Farmacologiche Mario Negri
- Responsible party
- Principal investigator, Enrica Cavedo, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Enrica Cavedo, PhD, Principal investigator, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382353
- Sponsor's protocol ID
- GR-2011-02350494
- Acronym
- EMuNI
- Status last verified
- Sep 2021
- First submitted
- 9 Dec 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22205763Cavedo 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.
PubMed 22672878Erickson 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.
PubMed 21282661Lampit 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.
PubMed 25405755Sperling 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.
PubMed 21514248Vemuri 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.
PubMed 23280791Rolandi 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.
PubMed 40366507
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multiple Nonpharmacological Interventions in Individuals With Subjective Memory Complaints
- ClinicalTrials.gov ID
- NCT03382353
- Acronym / sponsor ID
- EMuNI / GR-2011-02350494
- Conditions
- Lifestyle Risk Reduction
- Keywords
- primary prevention, Subjective Cognitive Decline, Neuroimaging, Alzheimer's disease, nonpharmacological interventions, multidomain lifestyle interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele, Istituto Di Ricerche Farmacologiche Mario Negri
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
- To investigate the combined effect of aerobic exercise, dietary habits, nutritional supplements, and cognitive training administered at three different levels of intensity on cognitive performance in subjective memory complaints individuals. The three different intensity levels of nonpharmacological treatments will be organized as follows: (i) No Treatment (NT) will include educational training (sham condition); (ii) Partial Treatment (PT) will include exclusively the consumption of a nutritional supplement and a training for a balanced diet; (iii) Full treatment (FT) will include all above condition plus computerized cognitive training (no sham condition) and aerobic fitness training.
- To investigate the effect of the above treatments (NT, PT, FT) on basic markers of magnetic resonance imaging (MRI) such as HV, WML and Brain Ventricle Volume (BVV) in subjective memory complaints individuals.
- To investigate the effect of NT, PT and FT on advanced MRI markers such as structural brain connectivity and brain resting networks in subjective memory complaints individuals.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Treatment (NT) | Active comparator | Behavioral: Educational trainingEducational training |
| Partial Treatment (PT) | Experimental | Dietary Supplement: Nutritional supplementation, Behavioral: Counselling on a brain-healthy dietNutritional supplementation \& Counselling on a brain-healthy diet |
| Full Treatment (FT) | Experimental | Dietary Supplement: Nutritional supplementation, Behavioral: Counselling on a brain-healthy diet, Behavioral: Physical exercise training, Behavioral: Computerized cognitive trainingNutritional supplementation \& Counselling on a brain-healthy diet \& Physical exercise training \& Computerized cognitive training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 60 and 80 years;
- presence of memory complaints
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementationDaily consumption of Tramiprosate (100 mg) for 1 year | Dietary supplement | Full Treatment (FT), Partial Treatment (PT) |
| Educational training16 educational lessons (twice a week): basic principles of different cognitive domains (e.g. memory, attention, perception) and educational DVD viewing. | Behavioural | No Treatment (NT) |
| Counselling on a brain-healthy diet4 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. | Behavioural | Full Treatment (FT), Partial Treatment (PT) |
| Physical exercise training80 sessions of physical exercise supervised by a Fitness Training Expert with the aim of achieving 150 minutes of moderate-intensity physical activity per week | Behavioural | Full Treatment (FT) |
| Computerized cognitive training16 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). | Behavioural | Full Treatment (FT) |
Primary outcome
Cognitive functions
Time frame: 12 months
Neuropsychological test performances
3 secondary outcomes
Basic imaging marker 1
Time frame: 12 months
Basic imaging marker 2
Time frame: 12 months
Basic imaging marker 3
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 22205763Bowman 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.
- Background: PubMed 22672878Cavedo 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.
- Background: PubMed 21282661Erickson 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.
- Background: PubMed 25405755Lampit 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.
- Background: PubMed 21514248Sperling 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.
- Background: PubMed 23280791Vemuri 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.
- Derived from this study: PubMed 40366507Rolandi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrica Cavedo, PhD principal investigator
IRCCS Centro San Giovanni di Dio Fatebenefratelli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation, Educational training and Counselling on a brain-healthy diet in people with Lifestyle Risk Reduction, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382353, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.