Cognitive InterventionNCT07747675
Cognitive Intervention for Cognitive Impairment
A study testing cognitive intervention in people with Cognitive Intervention and Mild Cognitive Impairment, run by Instituto Mexicano del Seguro Social.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Cognitive Intervention, Mild Cognitive Impairment, Elderly Adults
- What is being tested?
- cognitive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with disabling hearing and/or visual impairments, patients with paralysis, and patients with severe psychiatric illness.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cognitive Intervention to Improve Mild Cognitive Impairment in Older Adults: Randomized Double-blind Clinical Trial
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.
Read the detailed description
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.
- Being tested
- cognitive intervention
- Keywords
- Mild Cognitive Impairment, Cognitive intervention, Elderly adults, Diabetes Mellitus
- Medical subject headings
- Cognitive Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No 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 gruop | Experimental | 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. Receives: Other: cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (Week 0) to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, two-arm, parallel-group design with a total duration of 8 weeks. The Intervention Group will receive weekly cognitive-psychostimulation sessions based on the INAPAM Cognitive Stimulation Manual for Older Adults, providing participants with tools for continuous stimulation-addressing memory, attention, language, executive and visuospatial functions, abstraction, and orientation, while the Control Group will receive an intervention delivered by social work staff. This intervention will implement an Active and Healthy Aging program featuring 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erika Lorena Vega Silva, Instituto Mexicano del Seguro Social
- Investigators
- Erika L Vega Silva, Dr., Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747675
- Sponsor's protocol ID
- R-2025-101-043
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual data regarding demographic and anthropometric variables and primary clinical outcomes will be shared upon a justified written request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Intervention to Improve Mild Cognitive Impairment in Older Adults: Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07747675
- Acronym / sponsor ID
- R-2025-101-043
- Keywords
- Mild Cognitive Impairment, Cognitive intervention, Elderly adults, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, two-arm, parallel-group design with a total duration of 8 weeks. The Intervention Group will receive weekly cognitive-psychostimulation sessions based on the INAPAM Cognitive Stimulation Manual for Older Adults, providing participants with tools for continuous stimulation-addressing memory, attention, language, executive and visuospatial functions, abstraction, and orientation, while the Control Group will receive an intervention delivered by social work staff. This intervention will implement an Active and Healthy Aging program featuring 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No 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 gruop | Experimental | Other: cognitive interventionThe 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. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with disabling hearing and/or visual impairments, patients with paralysis, and patients with severe psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive interventionThe 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 | Intervention gruop |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual data regarding demographic and anthropometric variables and primary clinical outcomes will be shared upon a justified written request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika L Vega Silva, Dr. principal investigator
Instituto Mexicano del Seguro Social
Questions about this trial
What is this clinical trial studying?
A study testing cognitive intervention in people with Cognitive Intervention and Mild Cognitive Impairment, run by Instituto Mexicano del Seguro Social.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika L Vega Silva, Dr. (449-918-0610 ext. 41465, draevega3606@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the MoCA scale (time frame: Change from baseline (Week 0) to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.