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NCT Number: NCT07747675

Cognitive Intervention for Cognitive Impairment

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.

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Key information

About this study

Potential participants will be evaluated in Education Classroom 1 at UMF No. 7. After obtaining written informed consent, two instruments will be administered to the patients. First, a questionnaire gathering sociodemographic characteristics will be administered. The second measurement instrument will be the Montreal Cognitive Assessment (MoCA).

Randomization and assignment: Eligible participants will be assigned via simple random selection in a 1:1 ratio using a computer-generated block randomization sequence. Group assignment will be concealed using opaque, sealed, and sequentially numbered envelopes managed by an independent study coordinator who is not involved in patient care or assessment. Intervention phase (weeks 1 to 8): Group 1 (intervention) will receive the intervention based on the cognitive psychostimulation program outlined in the INAPAM Cognitive Stimulation Manual for Older Adults. Group 2 (control): Patients will receive an intervention delivered by social work staff, consisting of an Active and Healthy Aging program.

Upon completion of the intervention, the MoCA scale will be administered again to evaluate the effectiveness of the implemented program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Intervention

Other

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.

Primary outcomes

  1. Score on the MoCA scale

    Time frame: Change from baseline (Week 0) to Week 8

    Assessed using the MoCA scale (range of 0 to 30 points). Results are classified as follows: 0-25 points indicate mild cognitive impairment, while 26-30 points are considered normal.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana L García Zepeda, Dr.

CONTACT

[email protected]

449-918-0610 ext. 41465

Erika L Vega Silva, Dr.

CONTACT

[email protected]

449-918-0610 ext. 41465

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Cognitive Intervention to Improve Mild Cognitive Impairment in Older Adults: Randomized Double-blind Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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