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Age-Related Cognitive DeclineEMBRACENCT07628686

EMBRACE - From Vulnerable to Empowered: Implementation and Evaluation of a Multicomponent Program to Tackling Age-related Decline

A study testing EMBRACE Intervention in people with Age-Related Cognitive Decline, run by University Fernando Pessoa at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

EMBRACE is a randomized, controlled, multi-domain, blinded clinical trial involving 120 community-dwelling older adults at risk of cognitive decline, lasting 12 months. Participants are randomized 1:1 to either a multicomponent intervention group, including cognitive and language training, physical activity… Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Age-Related Cognitive Decline
What is being tested?
EMBRACE Intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 sitePortugal
Study dates
1 Jun 2026to 31 May 2029
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 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • MoCA ≥ 17 (Portuguese cutoff point to differentiate between mild cognitive impairment and dementia);
  • Bedside ≥ 20 for literate individuals or 12 for illiterate individuals.

Who cannot join

  • Malignant diseases;
  • Diagnosed major depressive disorder;
  • Dementia/substantial cognitive decline (MoCA < 17);
  • Symptomatic cardiovascular disease;
  • Revascularization within the last year;
  • Active malignancy;
Show all 13Show fewer
  • Severe loss of vision, hearing, or communication;
  • Contraindications for physical activity;
  • Neuromuscular diseases;
  • Severe musculoskeletal pathology;
  • Inability to walk independently;
  • Neurological disease affecting language functions;
  • Simultaneous participation in any intervention trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Portugal1 site
  • University Fernando Pessoa

    Porto, Porto District, 4249-004

    Carina Fernandes, +351 915101426, carinafernandes@ufp.edu.pt

Other trials in Portugal

About this study

EMBRACE is a randomized, controlled, multi-domain, blinded clinical trial involving 120 community-dwelling older adults at risk of cognitive decline, lasting 12 months. Participants are randomized 1:1 to either a multicomponent intervention group, including cognitive and language training, physical activity, nutritional counseling with oral health support, and financial and digital literacy education, or to a control group receiving regular health counseling. The trial evaluates the effects of the intervention on cognitive performance, quality of life, functionality, financial literacy, digital inclusion, and other health-related outcomes.

Read the detailed description

The EMBRACE program is a research initiative designed to address the increasing challenges of aging, particularly the risk of cognitive decline and dementia, vulnerability to economic fraud, and digital exclusion. The EMBRACE intervention is a multicomponent, non-pharmacological approach that includes cognitive training, linguistic stimulation, physical activity guidance, nutritional counseling, and education on financial and digital literacy. Through a carefully designed randomized controlled trial, this research project aims to evaluate the effectiveness of the EMBRACE program in improving the quality of life, functionality, and overall well-being of older adults.

By combining various aspects of health and well-being, the project aligns with the emphasis of the World Health Organization (WHO) on developing and implementing preventive strategies to reduce the risk of dementia. The innovative aspect of integrating financial and digital literacy education into the intervention recognizes the evolving challenges faced by the aging population, who are among the primary victims of economic fraud and particularly vulnerable to digital exclusion.

The primary beneficiaries of the EMBRACE program will be older adults who are at risk of developing cognitive decline or dementia. By equipping participants with tools and strategies to maintain cognitive health and physical well-being, the project aims to enhance quality of life. Moreover, the program's findings could inform public health policies and eldercare practices, potentially benefiting a broader spectrum of older adults by promoting strategies for active and healthy aging. In addition to direct participants, the project's outcomes are expected to benefit healthcare professionals, caregivers, and policymakers by providing validated approaches to prevent or delay cognitive decline among older adults. Furthermore, if the EMBRACE program proves successful, the investigators plan to integrate it into the curriculum of national senior universities and adapt it for digital platforms. This would enable global dissemination, extending its benefits to a broader audience worldwide.

Being tested
EMBRACE Intervention
Keywords
Aging, Cognitive stimulation, Physical activity, Financial and Digital literacy
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMBRACE InterventionCombination product

    This intervention will last 12 months and will consist of four components. The nutritional intervention includes 5 individual sessions (at the beginning of the study and at 3, 6, 9, and 12 months) and 12 group sessions (1 per month) based on the Mediterranean diet, with support for oral health. Financial and digital literacy will be addressed in monthly sessions, covering topics such as retirement, investments, and fraud prevention. Cognitive and linguistic training will take place twice a week (80 sessions), with activities adapted through the COGWEB platform and support from a speech therapist. Physical training will also be conducted twice a week, including aerobic exercise, strength training, balance training, and dual-task training, with intensity adjusted using the Borg scale.

Study groups in NCT07628686
Study groupRoleWhat they receive
Experimental GroupExperimental60 participants in the experimental group (EG) will receive an intensive multicomponent intervention consisting of nutrition and oral medicine; physical activity; cognitive training (or compensation in those cases in which participants revealed mild cognitive impairment at the baseline assessment); and financial and digital literacy education.
Receives: Combination Product: EMBRACE Intervention
Control GroupNo intervention60 participants in the control group will not undergo the EMBRACE intervention; they will only receive regular health advice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment (MoCA)

    General cognitive functions will be assessed using the MoCA. The MoCA is a cognitive screening instrument used to evaluate multiple cognitive domains, with scores ranging from 0 to 30, where higher scores indicate better cognitive performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  2. World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)

    Quality of life will be assessed using the WHOQOL-BREF. The WHOQOL-BREF is a questionnaire used to evaluate quality of life across physical, psychological, social relationships, and environmental domains, with scores ranging from 0 to 100, where higher scores indicate better quality of life.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

Secondary outcomes (26)
  1. d2 Test

    Selective attention and concentration ability will be assessed using the d2 Test. The d2 Test is a neuropsychological instrument used to evaluate selective attention, concentration, and processing speed through a timed cancellation task consisting of 14 lines to be completed in a maximum of 20 seconds per line. Performance is measured through task execution indices, concentration, processing speed, and error percentage. Higher scores on task execution and concentration indices, and lower error percentages, indicate better attentional performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  2. INECO Frontal Screening (IFS)

    Executive functions will be assessed using the IFS. The IFS is a cognitive screening instrument used to evaluate executive functioning, including inhibitory control, cognitive flexibility, working memory, and abstraction ability, with scores ranging from 0 to 30, where higher scores indicate better executive functioning.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  3. Stroop Test

    Inhibitory control, cognitive flexibility, and resistance to interference will be assessed using the Stroop Test. The Stroop Test consists of three tasks (word, color, and color-word), each administered within a maximum time of 45 seconds. Performance is measured by the number of words, colors, and stimuli correctly identified, where higher scores indicate better cognitive performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  4. Trail Making Test (TMT)

    Alternating attention, visual attention, and processing speed will be assessed using the TMT. The TMT is a neuropsychological instrument used to evaluate visual attention, alternating attention, and processing speed through a timed task requiring participants to connect a sequence of numbers and letters. Performance is measured by completion time in seconds, where shorter completion times indicate better cognitive performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  5. Spatial Span Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)

    Working memory will be assessed using the Spatial Span Subtest of the WMS-III. The Spatial Span Subtest is a neuropsychological instrument used to evaluate visuospatial working memory through forward and backward span tasks, with scores ranging from 0 to 32, where higher scores indicate better working memory performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  6. Logical Memory Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)

    Immediate and delayed verbal episodic memory will be assessed using the Logical Memory Subtest of the WMS-III. The Logical Memory Subtest is a neuropsychological instrument used to evaluate the recall and recognition of verbally presented information, with scores ranging from 0 to 75 for immediate recall, 0 to 30 for delayed recall, and 0 to 30 for recognition, where higher scores indicate better memory performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  7. Rey Auditory Verbal Learning Test (RAVLT)

    Verbal learning and memory will be assessed using the RAVLT. The RAVLT is a neuropsychological instrument used to evaluate verbal learning, immediate recall, delayed recall, and recognition memory through repeated presentation of a 15-word list. Performance is measured by the number of correctly recalled or recognized words across the assessment trials, where higher scores indicate better verbal learning and memory performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  8. Boston Naming Test (BNT)

    Naming ability will be assessed using the BNT. The BNT is a neuropsychological instrument used to evaluate confrontation naming ability through the identification of visually presented objects, with scores ranging from 0 to 60, where higher scores indicate better naming performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  9. Phonemic and Semantic Verbal Fluency Tests

    Verbal fluency and executive functions will be assessed through Phonemic and Semantic Verbal Fluency Tests. These neuropsychological tests are used to evaluate information retrieval from memory, executive functions (such as cognitive flexibility, planning, and inhibitory control), and language production through word generation within a maximum time frame of 1 minute for each task, where higher scores indicate better performance in verbal fluency.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  10. Instrumental Activities of Daily Living (IADL)

    Functionality in instrumental activities of daily living will be assessed using the IADL scale. The IADL scale is used to evaluate independence in everyday functional activities, with scores ranging from 8 to 31, where lower scores indicate greater functional independence.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  11. Hospital Anxiety and Depression Scale (HADS)

    Symptoms of anxiety and depression will be assessed using the HADS. The HADS is a self-report questionnaire used to evaluate symptoms of anxiety and depression, with scores ranging from 0 to 21 for each subscale, where higher scores indicate greater symptom severity.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  12. Numerical Activities of Daily Living - Financial (NADL-F)

    Financial literacy and functionality in numerical activities of daily living will be assessed using the NADL-F assessment. The NADL-F is used to evaluate financial abilities and numerical functioning in everyday activities across domains including money counting (scores ranging from 0 to 5), reading abilities (0 to 8), purchasing articles (0 to 14), percentages (0 to 9), financial concepts (0 to 14), bill payment (0 to 6), and financial judgment (0 to 6), where higher scores indicate better financial functioning and autonomy in daily life.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  13. Bedside Language Test

    Language abilities will be assessed using the Bedside Language Test. The Bedside Language Test is a language assessment tool used to evaluate speech, language comprehension, repetition, reading, and writing abilities, with scores ranging from 0 to 25, where higher scores indicate better language performance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  14. PREDIMED

    Adherence to the Mediterranean diet will be assessed using the PREDIMED questionnaire. The PREDIMED questionnaire is used to evaluate adherence to Mediterranean dietary patterns, with scores ranging from 0 to 14, where higher scores indicate greater adherence to the Mediterranean diet.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  15. International Physical Activity Questionnaire (IPAQ)

    Physical activity level will be assessed using the IPAQ. The IPAQ is used to evaluate the frequency, duration, and intensity of physical activity performed in daily life. Physical activity levels are calculated in MET-minutes per week based on the frequency and duration of walking and moderate- and vigorous-intensity activities, with higher scores indicating higher levels of physical activity.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  16. Timed Up and Go Test (TUG)

    Functional mobility and dynamic balance ability will be assessed using the TUG. The TUG is used to evaluate functional mobility and dynamic balance through the time required to stand up from a chair, walk a short distance, return, and sit down, with performance measured in seconds, where shorter completion times indicate better functional mobility and balance.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  17. Blood Pressure

    Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg). Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  18. Body Mass Index (BMI)

    Body mass index (BMI) will be calculated using body weight and height and expressed in kilograms per square meter (kg/m²). BMI is a measure of body size based on weight relative to height.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  19. Handgrip Strength

    Handgrip strength will be assessed using a hand dynamometer. Performance is measured in kilograms-force (kgf), where higher values indicate greater muscular strength.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  20. Blood Count

    Hematological status will be assessed using a blood count performed through blood analysis. Results will be reported according to standard laboratory reference units.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  21. Serum Magnesium

    Serum magnesium levels will be assessed through blood analysis and reported according to standard laboratory reference units.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  22. Serum Iron

    Serum iron levels will be assessed through blood analysis and reported according to standard laboratory reference units.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  23. Vitamin B12

    Vitamin B12 levels will be assessed through blood analysis and reported according to standard laboratory reference units.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up

  24. Decayed, Missing, and Filled Teeth Index (CPO-D)

    Oral health status will be assessed using the Decayed, Missing, and Filled Teeth Index (CPO-D). The CPO-D index is used to evaluate oral health status based on the number of decayed, missing, and filled teeth, where higher scores indicate poorer oral health status.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  25. Salivary pH Analysis

    Salivary condition and oral health status will be assessed using salivary pH analysis. Salivary pH values will be measured to evaluate salivary condition and oral health status, and will be reported according to standard pH units.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

  26. Dental Prosthesis Status

    Dental prosthesis status will be assessed through clinical oral examination. The assessment will evaluate the presence, type, functional status, and need for adjustment or replacement of dental prostheses.

    Measured: Baseline, post-intervention (12 months), and 6-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628686
Sponsor's protocol ID
COMPETE2030-FEDER-00892100
Acronym
EMBRACE
Status last verified
Jun 2026
First submitted
12 May 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vaz Serra et al. (2006). Estudos psicométricos do instrumento de avaliação da qualidade de vida da Organização Mundial de Saúde (WHOQOL-Bref) para português de Portugal. Psiquiatria Clínica, 27(1), 41-49

  • Araújo et al. (2008). Validação da escala de Lawton e Brody numa amostra de idosos não institucionalizados. In I. Pais-Ribeiro et al. (Eds.), Actas do 7º Congresso Nacional de Psicologia da Saúde (pp. 217-220). ISPA.

  • Cruz & Pais (2012). Cogweb-sistema integrado de estimulação cognitiva: Manual de formação para profissionais. Gaia: Neuroinova.

  • Fernandes C, Pasion R, Goncalves AR, Ferreira-Santos F, Barbosa F, Martins IP, Marques-Teixeira J. Age differences in neural correlates of feedback processing after economic decisions under risk. Neurobiol Aging. 2018 May;65:51-59. doi: 10.1016/j.neurobiolaging.2018.01.003. Epub 2018 Jan 17.

    PubMed 29407466
  • Kibby MY, Schmitter-Edgecombe M, Long CJ. Ecological validity of neuropsychological tests: focus on the California Verbal Learning Test and the Wisconsin Card Sorting Test. Arch Clin Neuropsychol. 1998 Aug;13(6):523-34.

    PubMed 14590636
  • Williams, N. 2017. The Borg Rating of Perceived Exertion (RPE) scale. Occupational Medicine, 67 (5), 404-5.

  • Tavares J, Faria A, Goncalves D, Mendes D, Silva S, Sousa L. Validation of the Portuguese version of the social isolation scale with a sample of community-dwelling older adults. Int J Nurs Sci. 2023 Mar 10;10(2):151-157. doi: 10.1016/j.ijnss.2023.03.002. eCollection 2023 Apr.

    PubMed 37128493
  • Wei, L., Peng, M., & Wu, W. 2021. Financial literacy and fraud detection--Evidence from China. International Review of Economics & Finance, 76, 478-94.

  • Fernandes, C., Macedo, I., Gonçalves, A. R., Pasion, R., Mata, R., Danese, G., Martins, I. P., Barbosa, F., & Marques-Teixeira, J. 2022. Neurophysiological examination of the Affect-Integration-Motivation framework of decision-making in the aging brain: A registered report Author links open overlay panel. NeuroImage, 256.

  • Fernandes C, Macedo I, Barbosa F, Marques-Teixeira J. Economic decision-making in the continuum between healthy aging and Alzheimer's Disease: A systematic review of 20 years of research. Neurosci Biobehav Rev. 2021 Dec;131:1243-1263. doi: 10.1016/j.neubiorev.2021.10.030. Epub 2021 Oct 29.

    PubMed 34715151
  • Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.

    PubMed 25940230
  • Bauman A, Ainsworth BE, Sallis JF, Hagstromer M, Craig CL, Bull FC, Pratt M, Venugopal K, Chau J, Sjostrom M; IPS Group. The descriptive epidemiology of sitting. A 20-country comparison using the International Physical Activity Questionnaire (IPAQ). Am J Prev Med. 2011 Aug;41(2):228-35. doi: 10.1016/j.amepre.2011.05.003.

    PubMed 21767731
  • Rolland Y, Abellan van Kan G, Nourhashemi F, Andrieu S, Cantet C, Guyonnet-Gillette S, Vellas B. An abnormal "one-leg balance" test predicts cognitive decline during Alzheimer's disease. J Alzheimers Dis. 2009;16(3):525-31. doi: 10.3233/JAD-2009-0987.

    PubMed 19276547
  • Benavent-Caballer V, Sendin-Magdalena A, Lison JF, Rosado-Calatayud P, Amer-Cuenca JJ, Salvador-Coloma P, Segura-Orti E. Physical factors underlying the Timed "Up and Go" test in older adults. Geriatr Nurs. 2016 Mar-Apr;37(2):122-7. doi: 10.1016/j.gerinurse.2015.11.002. Epub 2015 Dec 17.

    PubMed 26707544
  • Langhammer B, Stanghelle JK. The Senior Fitness Test. J Physiother. 2015 Jul;61(3):163. doi: 10.1016/j.jphys.2015.04.001. Epub 2015 Jun 1. No abstract available.

    PubMed 26044346

Questions about this trial

What is this clinical trial studying?

A study testing EMBRACE Intervention in people with Age-Related Cognitive Decline, run by University Fernando Pessoa at 1 site in Portugal.

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 2 inclusion and 13 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) (time frame: Baseline, post-intervention (12 months), and 6-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628686, which also lists 30 linked publications.

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 Jun 2026.

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