Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad — INTERCOG  

Mild Cognitive Impairment Clinical Trial

Official title: Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad

Status Not yet recruiting

Clinical Trial Summary

With the aging of the population, an increase in neurocognitive diseases such as dementia is projected. Mild cognitive impairment is considered a precursor stage to dementia, with opportunities for intervention to prevent its progression. Additionally, these illnesses can harm the primary caregiver, who is often an unskilled family member. This is a randomized clinical trial in patients with mild cognitive impairment and their main caregivers.

The intervention will be tested in the dyad for 12 weeks, twice a week with professional support and once a week with caregiver support, the latter will be intervened once a week for 12 weeks. The primary outcome will be the change in cognitive function and its domains. Secondary outcomes will evaluate favorable changes in quality of life in the patient-caregiver couple, frailty, physical capacity, independence, nutritional status, social support, and family caregiver burden. These measurements will be taken at baseline, 3, 6, and 9 months of follow-up. Furthermore, in a subsample of the study population, the taxonomic and metabolomic composition of the intestinal microbiota and the presence of the E4 allele of the APOE (apolipoprotein E) gene will be evaluated before and after the intervention.

Clinical Trial Description

Introduction: The aging of the population has led to an increase in the number of individuals with cognitive impairment and neurodegenerative diseases, resulting in greater disability and dependence among older adults worldwide. The prevalence of Mild Cognitive Impairment (MCI) is estimated to be approximately 16%, varying between 2% and 31%.

Multiple interventions have been tested to maintain or improve cognitive function in older adults, including cognitive-motor interventions, yoga, psychosocial and lifestyle interventions, as well as arts-based interventions (dance, theater, music, or visual arts). However, the literature indicates that multicomponent interventions (MCI), also known as multimodal or multidomain, are more effective compared to single-domain interventions in improving cognitive function in older adults.

General Objective: To evaluate the effectiveness of a multicomponent intervention focusing on cognitive function for the caregiver-patient dyad

Methods: Pilot randomized clinical trial, with 1:1 allocation in 102 patients with mild cognitive impairment and their primary caregivers/family members.

Results: The goal is to generate evidence on the efficacy and applicability of these interventions to create a care guide for the caregiver-patient dyad with cognitive impairment, tailored to the Colombian population, with the involvement of different institutions such as universities and healthcare providers. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT06408103
• Study type: Interventional
• Source: Universidad de Santander
• Contact: Diana Tiga Loza, Ph.D
• Phone: +57 (607) 6516500
• Email: dia.tiga@mail.udes.edu.co; caritotiga@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Completion date: February 28, 2025