MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline

Instituto de Saude Publica da Universidade do Porto

Status

Unknown

Conditions

Cognitive Impairment

Memory Disorders

Cognition Disorder

Cognitive Dysfunction

Neurocognitive Disorders

Treatments

Behavioral: Nutrition education

Behavioral: Capacitation to deal with cognitive decline

Behavioral: Diagnosis and correction of hearing impairment

Behavioral: Cognitive training

Behavioral: Physical exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05383443

63/CE/JAS/2020

Details and patient eligibility

About

The present study aims to quantify the impact of a multidomain approach to prevent cognitive decline in individuals from the general population at-high risk of dementia. It will be based on five distinct components: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss.

Full description

This is a community-based randomized controlled trial (RCT), which will be implemented in Matosinhos municipality (Portugal) and will be conducted over three months, possibly extensible up to 12 months.

Eligible individuals (n=300) will be randomized (1:1) into two arms: intervention and control groups. The intervention plan will be composed by five non-pharmacological strategies, namely: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss. This plan will be applied to both groups, but with lower intensity among the control group.

Participants' characteristics will be assessed at baseline and at three months; for those who complete one year of intervention, additional follow-ups at six and 12 months after the beginning of the intervention will be conducted. These evaluations will cover the following domains: sociodemographic, lifestyle, health and anthropometric characteristics; cognitive function; subjective memory complains; symptoms of anxiety and depression; quality of life; physical performance; levels of glycated hemoglobin and 24-hour urinary sodium, potassium, creatinine excretion as well as pH.

The results of the present study may guide future clinical practices and health policies aiming to prevent cognitive decline and reduce the overall burden of dementia.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-85 years;
Score equal or higher than the validated cutoff points defined as 2 standard deviations below the mean for age and education in the Montreal Cognitive Assessment (MoCA);
≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE);
≥4 years of schooling.

Exclusion criteria

Medical disability that contraindicates physical activity;
Lack of autonomy in daily activities;
Previous diagnosis of dementia or severe incapacity.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Intervention

Experimental group

Description:

Multidomain non-pharmacological intervention, including cognitive training, physical exercise, nutrition education, capacitation to deal with cognitive decline, and diagnosis and correction of hearing impairment. The intervention plan includes home training activities of identical intensity for participants with and without access or autonomy to use computer/internet. It will comprise individual and group sessions over three months, possibly extensible up to 12 months. Caregivers or partners of all participants will be invited to participate in the activities of nutrition education and capacitation to deal with cognitive decline.

Treatment:

Behavioral: Cognitive training

Behavioral: Physical exercise

Behavioral: Capacitation to deal with cognitive decline

Behavioral: Physical exercise

Behavioral: Cognitive training

Behavioral: Nutrition education

Behavioral: Capacitation to deal with cognitive decline

Control group

Active Comparator group

Description:

Multidomain non-pharmacological intervention, including cognitive training, physical exercise, nutrition education, capacitation to deal with cognitive decline, and diagnosis and correction of hearing impairment. It will comprise individual and group sessions, over three months (possibly extensible up to 12 months), conducted with a lower frequency in comparison with the intervention group. Caregivers or partners of all participants will be invited to participate in the activities of nutrition education and capacitation to deal with cognitive decline.

Treatment:

Behavioral: Diagnosis and correction of hearing impairment

Behavioral: Cognitive training

Behavioral: Physical exercise

Behavioral: Capacitation to deal with cognitive decline

Behavioral: Physical exercise

Behavioral: Cognitive training

Behavioral: Nutrition education

Behavioral: Capacitation to deal with cognitive decline