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Background <p>Given the risk of progression to dementia ranging from 6 to 44.8% over approximately 4&#xa0;years of follow-up, nonpharmacological multicomponent interventions are emerging as promising strategies to improve or maintain cognitive function and quality of life in individuals with mild cognitive impairment (MCI). This pilot study aims to evaluate the feasibility and potential efficacy of a multicomponent and transdisciplinary intervention focused on the dyad of older adults with MCI–family study partner to promote cognitive function in older adults.</p> Methods <p>A pilot, randomized, controlled, and double-blind clinical trial will be conducted with 102 dyads consisting of an older adult with MCI and their family study partner. The participants will be randomly assigned to two groups: the intervention group (INTERCOG) and the control group. The INTERCOG group will receive a 12-week home-based intervention (twice weekly) with the support of a healthcare professional. The intervention components consist of cognitive training and stimulation, nutritional counseling, and physical exercises. Simultaneously, family members will participate in a training program on care and self-care. The control group will receive an Enhanced Standard of Care with educational messages on infection prevention. The feasibility of the study will be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges; also, changes in global cognition and changes in specific cognitive domains will be measured as exploratory results. Secondary outcomes will include changes in health-related quality of life, caregiver burden, social support for family members, as well as changes in functional independence, frailty, physical capacity, family functioning, and nutritional status in patients, with follow-up at 3, 6, and 9&#xa0;months. In a subsample of 40 participants, the diversity of the gut microbiota will be characterized, and the frequency of the APOE-ε4 allele will be determined.</p> Discussion <p>Multicomponent and transdisciplinary interventions focused on the family member–patient dyad have the potential to optimize cognitive outcomes and quality of life. This pilot study will allow us to identify key aspects of the feasibility and potential efficacy of INTERCOG intervention, crucial information for the design of future larger-scale studies.</p> Trial registration <p>NCT06408103. December 6, 2024, at clinicaltrials.gov. In recruitment.</p>

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Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial—INTERCOG study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月27日

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  • Diana Carolina Tiga-Loza,
  • William Armando Álvarez-Anaya,
  • Raquel Rivera-Carvajal,
  • Ariel Calderón Ardila,
  • Jhosman Alfonso Buitrago-Buitrago,
  • Alexander Pabon,
  • Álvaro Castañeda-Hernández,
  • Mabel Margoth Reyes-Pulido,
  • Katherine Prado Guzmán,
  • Hadder Uriel Acosta Salazar,
  • Edwing Alberto Urrea-Vega,
  • Lina María Carreño-Parra,
  • Paul Anthony Camacho

摘要

Background

Given the risk of progression to dementia ranging from 6 to 44.8% over approximately 4 years of follow-up, nonpharmacological multicomponent interventions are emerging as promising strategies to improve or maintain cognitive function and quality of life in individuals with mild cognitive impairment (MCI). This pilot study aims to evaluate the feasibility and potential efficacy of a multicomponent and transdisciplinary intervention focused on the dyad of older adults with MCI–family study partner to promote cognitive function in older adults.

Methods

A pilot, randomized, controlled, and double-blind clinical trial will be conducted with 102 dyads consisting of an older adult with MCI and their family study partner. The participants will be randomly assigned to two groups: the intervention group (INTERCOG) and the control group. The INTERCOG group will receive a 12-week home-based intervention (twice weekly) with the support of a healthcare professional. The intervention components consist of cognitive training and stimulation, nutritional counseling, and physical exercises. Simultaneously, family members will participate in a training program on care and self-care. The control group will receive an Enhanced Standard of Care with educational messages on infection prevention. The feasibility of the study will be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges; also, changes in global cognition and changes in specific cognitive domains will be measured as exploratory results. Secondary outcomes will include changes in health-related quality of life, caregiver burden, social support for family members, as well as changes in functional independence, frailty, physical capacity, family functioning, and nutritional status in patients, with follow-up at 3, 6, and 9 months. In a subsample of 40 participants, the diversity of the gut microbiota will be characterized, and the frequency of the APOE-ε4 allele will be determined.

Discussion

Multicomponent and transdisciplinary interventions focused on the family member–patient dyad have the potential to optimize cognitive outcomes and quality of life. This pilot study will allow us to identify key aspects of the feasibility and potential efficacy of INTERCOG intervention, crucial information for the design of future larger-scale studies.

Trial registration

NCT06408103. December 6, 2024, at clinicaltrials.gov. In recruitment.