Nonpharmacological Multicomponent Intervention for Mild Cognitive Impairment with a Family-Patient Approach: Protocol for the Pilot Clinical Trial-INTERCOG Study

Background Given the absence of effective pharmacological treatments and the risk of progression to dementia ranging from 6–44.8% over approximately 4 years of follow-up, nonpharmacologicalmulticomponent 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 potential efficacy and feasibility of a multicomponent and transdisciplinary intervention focused on the dyad of older adults with MCI-family caregivers 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 caregiver. 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 (two weekly sessions) 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 standard care and educational messages on infection prevention. Changes in global cognition (MMSE and MoCA) and in specific cognitive domains will be measured. The feasibility of the study will also be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges. 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 caregiver–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, atclinicaltrials.gov. In recruitment