EMuNI Project: Multiple Nonpharmacological Interventions

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli (Other)

Overall Status

Completed

CT.gov ID

NCT03382353

Collaborator

Ospedale San Raffaele (Other), Istituto Di Ricerche Farmacologiche Mario Negri (Other)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lifestyle Risk Reduction	Dietary Supplement: Nutritional supplementation Behavioral: Educational training Behavioral: Counselling on a brain-healthy diet Behavioral: Physical exercise training Behavioral: Computerized cognitive training	N/A

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

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Multiple Nonpharmacological Interventions in Individuals With Subjective Memory Complaints

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: No Treatment (NT) Educational training	Behavioral: Educational training 16 educational lessons (twice a week): basic principles of different cognitive domains (e.g. memory, attention, perception) and educational DVD viewing.
Experimental: Partial Treatment (PT) Nutritional supplementation & Counselling on a brain-healthy diet	Dietary Supplement: Nutritional supplementation Daily consumption of Tramiprosate (100 mg) for 1 year Behavioral: Counselling on a brain-healthy diet 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.
Experimental: Full Treatment (FT) Nutritional supplementation & Counselling on a brain-healthy diet & Physical exercise training & Computerized cognitive training	Dietary Supplement: Nutritional supplementation Daily consumption of Tramiprosate (100 mg) for 1 year Behavioral: Counselling on a brain-healthy diet 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. Behavioral: Physical exercise training 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 Behavioral: Computerized cognitive training 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).

Arm

Intervention/Treatment

Active Comparator: No Treatment (NT)

Educational training

Behavioral: Educational training

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

Experimental: Partial Treatment (PT)

Nutritional supplementation & Counselling on a brain-healthy diet

Dietary Supplement: Nutritional supplementation

Daily consumption of Tramiprosate (100 mg) for 1 year

Behavioral: Counselling on a brain-healthy diet

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.

Experimental: Full Treatment (FT)

Nutritional supplementation & Counselling on a brain-healthy diet & Physical exercise training & Computerized cognitive training

Dietary Supplement: Nutritional supplementation

Daily consumption of Tramiprosate (100 mg) for 1 year

Behavioral: Counselling on a brain-healthy diet

Behavioral: Physical exercise training

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

Behavioral: Computerized cognitive training

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).

Outcome Measures

Primary Outcome Measures

Cognitive functions [12 months]
Neuropsychological test performances

Secondary Outcome Measures

Basic imaging marker 1 [12 months]
Hippocampal volumes
Basic imaging marker 2 [12 months]
White matter hyperintensities volumes
Basic imaging marker 3 [12 months]
Brain ventricle volumes

Other Outcome Measures

Advanced imaging marker 1 [12 months]
Structural brain connectivity
Advanced imaging marker 2 [12 months]
Functional networks connectivity at rest

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age between 60 and 80 years;
presence of memory complaints

Exclusion Criteria:

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