CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Nutritional supplementation +4 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382353
NCT03382353N/ACompleted

Efficacy of Multiple Nonpharmacological Interventions in Individuals With Subjective Memory Complaints

IRCCS Centro San Giovanni di Dio Fatebenefratelli·interventional·Posted Dec 22, 2017·Updated Sep 14, 2021

In Brief

A clinical study evaluating Nutritional supplementation, Educational training, and 3 other interventions for Lifestyle Risk Reduction. Completed, enrolled 120 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2017
Enrollment StartJan 1, 2016
Primary CompletionJun 1, 2017
Study CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.5 years ago

Interventions

Nutritional supplementationdietary

Daily consumption of Tramiprosate (100 mg) for 1 year

Educational trainingbehavioral

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 dietbehavioral

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 trainingbehavioral

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 trainingbehavioral

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).