Cognitive Intervention for Cognitive Impairment | NCT07747675

NCT07747675

Overview

NCT ID: NCT07747675
Lead Sponsor: Instituto Mexicano del Seguro SocialOTHER_GOV
Official Title: Cognitive Intervention to Improve Mild Cognitive Impairment in Older Adults: Randomized Double-blind Clinical Trial
Brief Summary: Mild cognitive impairment is characterized by cognitive dysfunction without impairment in instrumental activities of daily living, with aging being the primary risk factor. Cognitive interventions employ stimulation and training techniques to address this impairment.

Objective: To determine the effect of a cognitive intervention on mild cognitive impairment in older adults with type 2 diabetes mellitus.

Methods: A double-blind, randomized clinical trial involving 102 patients, who will be assigned to either a control group or an intervention group. Data collection will utilize a sociodemographic profile questionnaire and the Montreal Cognitive Assessment (MoCA). The cognitive intervention will be implemented over an average period of two months per subgroup, consisting of eight weekly, 60-minute sessions. Analysis will be conducted using descriptive statistics, and a linear mixed-effects model for repeated measures will be applied to evaluate the intervention's effect.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Aug 3, 2026Estimated
Primary Completion Date: Sep 30, 2026Estimated

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Affiliation with IMSS Aguascalientes Family Medicine Unit (UMF) No. 7; age 65 to 95 years; male or female; known diagnosis of type 2 diabetes mellitus; any level of education; any occupation; presence of mild cognitive impairment; availability to attend cognitive intervention sessions; and signing of informed consent.

Exclusion Criteria:

Patients with disabling hearing and/or visual impairments, patients with paralysis, and patients with severe psychiatric illness.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 102Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
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Contacts and Locations

Central Contacts: Erika L Vega Silva, Dr.Contact
draevega3606@gmail.com

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Participant Group/Arms

Control groupNo Intervention

The control group will receive an intervention delivered by social work staff, involving the implementation of an Active and Healthy Aging program that includes cognitive rehabilitation workshops as well as physical, emotional, social, and functional stimulation, with the aim of providing rehabilitation to older adults in the emotional, functional, and cognitive domains.

Intervention gruopExperimental

The intervention will be administered by two family medicine physicians trained in implementing the cognitive intervention. This intervention will utilize a cognitive-psychostimulation program based on INAPAM's Cognitive Stimulation Manual for Older Adults, which provides participants with tools for continuous stimulation, addressing memory, attention, language, executive and visuospatial functions, abstraction, and orientation.

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