An interventional study of cognitive intervention in Cognitive Intervention, Mild Cognitive Impairment and Elderly Adults, sponsored by Instituto Mexicano del Seguro Social. Not yet recruiting. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Treatment
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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.
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.
3,876 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 102 is above the median of 64 across 2,797 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Other: cognitive intervention
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.
Score on the MoCA scale
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.
Time frame: Change from baseline (Week 0) to Week 8
No study locations are listed for this record.
Plan to share: Yes — Anonymized individual data regarding demographic and anthropometric variables and primary clinical outcomes will be shared upon a justified written request.
Supporting information: Statistical analysis plan, Analytic code
Time frame: Starting six months after the article's publication, for a period of three years.
Access criteria: Academic researchers who submit a methodologically sound proposal and request data in writing.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.
Of 1,449 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 1 month is below that.
Counting every sponsor, half of 1,518 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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