NCT07668440

Brief Summary

Mexico exhibits a high prevalence of dementia, exceeding 8%, and it is estimated that by 2050 around 3.5 million older adults will be living with this condition. In light of this scenario, addressing factors associated with dementia development through preventive strategies is a priority, particularly through multicomponent programs that integrate physical activity, cognitive training, and other lifestyle-modification components, implemented early before the onset of clinical symptoms. To expand access to this type of intervention for older adults with limited time or resources for in-person care, remote preventive programs delivered by digital media have been launched. Web platforms constitute an accessible and cost-effective alternative for delivering complex interventions, such as the "Mind and Movement for Cognitive Health (MeMo-Salud-Cog)" program, which is designed to promote lifestyles conducive to cognitive health and has shown promising preliminary results in overall cognitive function, memory, executive function, and attention. However, the use of digital systems by older adults may be limited by barriers associated with aging (cognitive, sensory, physical, and motivational), as well as social factors (education and social isolation) or cultural factors (beliefs and perceived usefulness), which can affect the continuity of their participation. In this context, the present proposal suggests adapting the MeMo-Salud-Cog program to a remote modality, through a website and remote monitoring by healthcare professionals, with the aim of evaluating its feasibility based on usability, satisfaction, effect, and adherence, as well as analysing perceived acceptability, with an emphasis on the barriers and benefits of remote intervention. The investigators will employ a mixed design combining quantitative and qualitative methods, with a pre-post evaluation without a control group in the quantitative part and semi-structured interviews in the qualitative part (pilot study). The study population will consist of independent individuals aged 60 to 75 years affiliated with IMSS at Family Medicine Units 1 and 28, with or without cognitive complaints but without impairment (MMSE ≥ 24), with functional independence, at least one vascular risk factor, a mobile phone or computer, and a signed informed consent form.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Oct 2027

First Submitted

Initial submission to the registry

June 5, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

July 6, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

June 5, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

ExerciseCognitive Trainingcognitioncognitive impairmentolder adultsprevention

Outcome Measures

Primary Outcomes (6)

  • Subjective cognitive enhancing.

    Through a questionnaire, the subjective memory complaint will be assessed by responding positively (≥1) or negatively (≤0) to questions such as: Do you feel you have trouble remembering things? Do you forget conversations? Do you repeat the same questions several times? Have you recently forgotten to turn off the stove? Do you think you have memory problems? Higher scores mean worse outcomes.

    Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

  • Cognitive enhancers-global-MoCA

    The assessment will be conducted using: a) The Montreal Cognitive Assessment (MoCA), which scores from 0 to 30 points, and higher scores indicate a better outcome.

    Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

  • Cognitive enhancers-psycological (executive function and mental flexibility)

    Executive function and mental flexibility will be assessed using the Trail Making Tests, Part A and Part B (TMT-A and TMT-B). The results of these tests are expressed as the time, in seconds, each task takes to complete. Processing speed, measured with the Digit Symbol Substitution Test (DSST), will be determined by the total number of correct number matches (higher scores indicate better performance). Higher scores indicate a worse outcome. And symbols achieved in 90 seconds (higher scores mean a worse outcome).

    Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

  • Cognitive enhancers-global-Blessed

    The Blessed Dementia Scale (Spanish version) comprises three sections: i) changes in daily activities (8 questions), ii) changes in habits (3 questions), and iii) changes in personality, interests, and impulses (11 questions), with a total score ranging from 0 to 28 (higher scores mean worse outcome).

    Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

  • Cognitive enhancers-psychological (memory)

    Everyday memory will be evaluated with the Rivermead Behavioral Memory Test (RBMT). This test uses a scale from 0 to 12 points, based on subtests that cover: recalling names, personal objects, and appointments; recognizing images and faces; recalling stories, routes, and messages immediately and after a delay; and orientation and date (higher scores indicate a better outcome).

    Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

  • Cognitive enhancers-psychological (verbal fluency)

    Verbal fluency (including semantic, animal naming, and phonetic fluency) will be assessed using the Controlled Oral Word Association Test (COWA). It will be determined by the total number of words identified in each category and letter (higher scores indicate a better outcome).

    Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

Secondary Outcomes (1)

  • Digital usability

    Measurements will be collected at 1 and 3 months, and the difference between the two assessments will be calculated.

Other Outcomes (3)

  • Perception of the risk and severity of memory decline or loss.

    Up to 12 weeks

  • Perception of barriers to intervention.

    Up to 12 weeks.

  • Perception of benefits and suggestions to intervention.

    Up to 12 weeks.

Study Arms (1)

MeMo-Health-Cog- remote

OTHER

MeMo-Health-Cog- remote

Other: Multi-domain intervention: Physical activity, cognitive training, and educational program through a website

Interventions

MeMo- Health- Cog Remote is a Multidomain intervention lasting 60 minutes, comprising 30 minutes of aerobic exercise, 20 minutes of cognitive training, and 5 minutes each for warm-up and cool-down. It is delivered at least three times weekly for 12 weeks. The weekly educational topic can also be reviewed on the same page, covering subjects such as active aging, healthy eating, and socialization. Participants access the program through a website, with options to watch the videos on TV.

MeMo-Health-Cog- remote

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With and without cognitive complaints (i.e., they have responded 'yes' to the question: 'Do you feel that your memory or learning abilities have worsened recently?").
  • They demonstrate independence in activities of daily living and instrumental activities of daily living. • With one or more vascular risk factors (for example, type 2 diabetes or hypertension).
  • With a score on the overall cognitive function test of≥ 24 on the Mini-Mental State Examination.
  • With a score between 0-4 on the Blessed Dementia Scale.
  • With a mobile phone or computer.
  • Have a companion, such as a child, spouse, or friend, who can support you during the assessment in case of an emergency.
  • Voluntary acceptance to participate in the study through a signed informed consent form prior to your participation.

You may not qualify if:

  • Depression (score \> 15 according to the Epidemiological Studies Center Depression Scale - Revised \[CESD-R\]).
  • With a clinical diagnosis of any significant neurological or psychiatric disorder (for example, Parkinson's disease, schizophrenia).
  • With any heart disease.
  • Presence of a recent cancer diagnosis.
  • History of recent severe cardiovascular event (for example, myocardial infarction, stroke).
  • Significant orthopedic conditions (for example, severe osteoarthritis).
  • Uncontrolled blood pressure (very high \> 180/100 mmHg or very low \< 100/60 mmHg).
  • Severe visual or hearing impairment.
  • Type 2 Diabetes Mellitus requires insulin to control hyperglycemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avenida Cuahutémoc 330

Mexico City, Mexico City, 06401, Mexico

Location

Related Publications (11)

  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

    PMID: 34785096BACKGROUND
  • Contreras Sanchez SE, Doubova SV, Martinez Vega IP, Grajales Alvarez R, Villalobos Valencia R, Dip Borunda AK, Lio Mondragon L, Martinez Pineda WJ, Nunez Cerrillo JG, Huerta Lopez AD, Zalapa Velazquez R, Mendoza Ortiz V, Vazquez Zamora VJ, Montiel Jarquin AJ, Garcia Galicia A, Talamantes Gomez EI, Sanchez Reyes R, Aguirre Gomez J, Ayala Anzures ME, Zapata Tarres M, Monroy A, Leslie HH. Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention. BMJ Open. 2024 Jun 21;14(6):e087240. doi: 10.1136/bmjopen-2024-087240.

    PMID: 38908841BACKGROUND
  • Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.

    PMID: 26146089BACKGROUND
  • Wildenbos GA, Peute L, Jaspers M. Aging barriers influencing mobile health usability for older adults: A literature based framework (MOLD-US). Int J Med Inform. 2018 Jun;114:66-75. doi: 10.1016/j.ijmedinf.2018.03.012. Epub 2018 Mar 27.

    PMID: 29673606BACKGROUND
  • Lochner J, Carlbring P, Schuller B, Torous J, Sander LB. Digital interventions in mental health: An overview and future perspectives. Internet Interv. 2025 Apr 2;40:100824. doi: 10.1016/j.invent.2025.100824. eCollection 2025 Jun.

    PMID: 40330743BACKGROUND
  • Bott NT, Hall A, Madero EN, Glenn JM, Fuseya N, Gills JL, Gray M. Face-to-Face and Digital Multidomain Lifestyle Interventions to Enhance Cognitive Reserve and Reduce Risk of Alzheimer's Disease and Related Dementias: A Review of Completed and Prospective Studies. Nutrients. 2019 Sep 19;11(9):2258. doi: 10.3390/nu11092258.

    PMID: 31546966BACKGROUND
  • Frisoni GB, Altomare D, Ribaldi F, Villain N, Brayne C, Mukadam N, Abramowicz M, Barkhof F, Berthier M, Bieler-Aeschlimann M, Blennow K, Brioschi Guevara A, Carrera E, Chetelat G, Csajka C, Demonet JF, Dodich A, Garibotto V, Georges J, Hurst S, Jessen F, Kivipelto M, Llewellyn DJ, McWhirter L, Milne R, Minguillon C, Miniussi C, Molinuevo JL, Nilsson PM, Noyce A, Ranson JM, Grau-Rivera O, Schott JM, Solomon A, Stephen R, van der Flier W, van Duijn C, Vellas B, Visser LNC, Cummings JL, Scheltens P, Ritchie C, Dubois B. Dementia prevention in memory clinics: recommendations from the European task force for brain health services. Lancet Reg Health Eur. 2023 Jan 31;26:100576. doi: 10.1016/j.lanepe.2022.100576. eCollection 2023 Mar.

    PMID: 36895446BACKGROUND
  • Altomare D, Molinuevo JL, Ritchie C, Ribaldi F, Carrera E, Dubois B, Jessen F, McWhirter L, Scheltens P, van der Flier WM, Vellas B, Demonet JF, Frisoni GB; European Task Force for Brain Health Services. Brain Health Services: organization, structure, and challenges for implementation. A user manual for Brain Health Services-part 1 of 6. Alzheimers Res Ther. 2021 Oct 11;13(1):168. doi: 10.1186/s13195-021-00827-2.

    PMID: 34635163BACKGROUND
  • Mukadam N, Sommerlad A, Huntley J, Livingston G. Population attributable fractions for risk factors for dementia in low-income and middle-income countries: an analysis using cross-sectional survey data. Lancet Glob Health. 2019 May;7(5):e596-e603. doi: 10.1016/S2214-109X(19)30074-9.

    PMID: 31000129BACKGROUND
  • Ribeiro F, Teixeira-Santos AC, Caramelli P, Leist AK. Prevalence of dementia in Latin America and Caribbean countries: Systematic review and meta-analyses exploring age, sex, rurality, and education as possible determinants. Ageing Res Rev. 2022 Nov;81:101703. doi: 10.1016/j.arr.2022.101703. Epub 2022 Aug 3.

    PMID: 35931410BACKGROUND
  • Acosta I, Borges G, Aguirre-Hernandez R, Sosa AL, Prince M; 10/66 Dementia Research Group. Neuropsychiatric symptoms as risk factors of dementia in a Mexican population: A 10/66 Dementia Research Group study. Alzheimers Dement. 2018 Mar;14(3):271-279. doi: 10.1016/j.jalz.2017.08.015. Epub 2017 Oct 10.

    PMID: 29028481BACKGROUND

MeSH Terms

Conditions

Motor ActivityCognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

BehaviorCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Rosalinda Senior Researcher A, PhD

CONTACT

Jessica Camacho Ruíz, M.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Clinical trials with a single arm
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator in Epidemiology

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 25, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

July 2, 2027

Study Completion (Estimated)

October 29, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations