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NCT Number: NCT07698431

Personalized Brain Health Service and Dementia Prevention

This study evaluates the feasibility of implementing a Brain Health Service (BHS) to assess and reduce dementia risk in individuals with Subjective Cognitive Decline (SCD). A total of 120 participants will be recruited from the Cognitive Disorders Unit at Hospital del Mar and randomly assigned to either a personalized intervention group or a control group receiving general prevention advice.

The study will assess individual biological and lifestyle-related risk factors for dementia and use validated tools to estimate each participant's risk profile. Participants in the intervention group will be offered a structured dementia risk communication and counseling process, with the option to receive or decline their individual risk estimate.

The intervention consists of a 6-month multimodal program combining digital and in-person strategies tailored to each participant's risk level. These strategies include personalized recommendations to improve lifestyle factors such as diet, physical activity, sleep, social engagement, and cognitive stimulation.

The main objectives are to evaluate the feasibility of delivering this type of service, including recruitment, adherence, and retention; to assess the psychological impact of communicating dementia risk; and to examine changes in lifestyle behaviors and cognitive outcomes over time compared with a control group.

This study addresses the need for early, personalized prevention strategies for individuals with SCD and may inform broader implementation of preventive BHS.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundació Pasqual Maragall

Barcelona, Catalonia, 08005, Spain

Location contact

Ana Fernández-Arcos, PhD

SUB_INVESTIGATOR

Andrea Horta-Barba, PhD

SUB_INVESTIGATOR

Anna Soteras Prat

CONTACT

[email protected]

+34 933 26 31 90

Natàlia Soldevila Domènech, PhD

SUB_INVESTIGATOR

Oriol Grau-Rivera, PhD

PRINCIPAL_INVESTIGATOR

About this study

The scientific literature highlights the potential of dementia prevention, with studies showing decreasing incidence rates in developed countries and clinical trials demonstrating the benefits of multimodal lifestyle interventions. However, translating this evidence into clinical practice requires further scientific validation.

Subjective Cognitive Decline (SCD) refers to individuals who report cognitive complaints despite normal performance on standardized cognitive tests. This population is increasingly represented in memory clinics, accounting for approximately 20-30% of consultations in some European centers. Individuals with SCD have an increased risk of developing mild cognitive impairment and dementia compared with those without cognitive complaints, and SCD may represent an early clinical manifestation of neurodegenerative disease. However, current clinical pathways are primarily oriented toward diagnosis and management of established impairment, and individuals with SCD are often discharged without access to personalized risk assessment or prevention strategies.

Brain Health Services (BHS) have been proposed as a new clinical model to address this gap. These services aim to provide comprehensive dementia risk assessment, individualized risk communication, and tailored prevention strategies. Core components include the evaluation of modifiable and biological risk factors, the use of validated algorithms for risk stratification, structured and ethically sound risk communication, and personalized interventions targeting multiple domains of brain health.

The B-HEALTH project is a proof-of-concept longitudinal study designed to evaluate the feasibility and preliminary impact of implementing a Brain Health Service in a real-world clinical setting. A total of 120 participants with SCD will be recruited from the Cognitive Disorders Unit at Hospital del Mar and randomly assigned to either an intervention group or a control group receiving general dementia prevention advice.

Participants will undergo a comprehensive risk assessment integrating clinical, lifestyle, and biological information. Individual dementia risk profiles will be generated using validated risk scores (e.g., LIBRA index) and blood-based markers of Alzheimer's Disease (AD) pathology (ptau-217). Participants in the intervention group will be offered a structured Dementia Risk Communication and Counseling process and may choose whether or not to receive their individualized risk estimate.

Following this, participants in the intervention group will receive a 6-month multimodal prevention program tailored to their level of dementia risk. The intervention targets physical activity, nutrition, sleep, cognitive stimulation, psychoeducation, and social engagement. The intensity of the intervention will be adapted according to individual risk level.

The program combines digital health (eHealth) tools with in-person components. These include a mobile application and a fitness tracker for continuous monitoring and feedback on lifestyle behaviours and sleep, digital cognitive assessments, and computerized cognitive training.

The primary objective of the study is to evaluate the feasibility of implementing this personalized risk stratification and prevention model in a clinical setting, including recruitment, adherence, and retention. Secondary objectives include assessing the psychological impact and acceptability of dementia risk communication, and exploring the effects of the multimodal intervention on lifestyle behaviors and cognitive outcomes. Additional exploratory analyses will examine associations between modifiable and biological risk factors and longitudinal cognitive performance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants aged 55 to 85 with subjective cognitive complaints and normal screening test performance at the hospital.
  • Participants must have a minimal educational level for a neuropsychological assessment and a minimal digital literacy for the usage of smartphones, computers and Internet.

Exclusion criteria

  • Objective cognitive impairment.
  • Clinically relevant neurological disorders.
  • Major psychiatric disorders.
  • History of drug/alcohol abuse.
  • Unstable medical conditions that could fully explain cognitive complaints, as determined by the investigator.

Treatment and study plan

multimodal lifestyle intervention

Behavioral

The intervention is a 6-month personalized, multimodal dementia risk reduction program based on individual risk stratification. Risk profiles are defined using modifiable and non-modifiable risk factors for Alzheimer's disease, allowing participants to be categorized into low, intermediate, or high-risk groups.

All participants in the intervention arm will receive structured and personalized counseling delivered through a mobile application.

Participants in the intermediate- and high-risk groups will additionally be invited to:

(i) complete individual 30-minute cognitive training sessions 2 to 3 times per week via a telematic platform, and (ii) attend monthly psychoeducational group sessions led by a psychologist or trained nurse.

Participants in the high-risk group will further be invited to attend individual nutrition counseling visits (one session per month) and supervised group-based physical activity sessions in a gymnasium setting (one session per week).

Other names: Non-pharmacological intervention

Lifestyle Recommendations and Counseling

Behavioral

Standard recommendations on dementia risk reduction will be provided at the beginning of the study, based on general guidance for maintaining brain health. Participants will have access to a mobile application providing educational information on dementia risk factors and healthy lifestyle behaviors. The content will be static and non-interactive, without personalized feedback or tailored recommendations

Other names: General Lifestyle Recommendations

Primary outcomes

  1. Feasibility of the multimodal intervention

    Time frame: 6 months

    Feasibility will be assessed using recruitment, adherence, and retention rates:

    • Recruitment rate: proportion of participants randomized among those eligible and invited to participate. A rate ≥50% will be considered successful.
    • Adherence: defined as completion of at least 50% of intervention components, including ecological momentary assessments (EMAs), online questionnaires, in-person activities, and cognitive training sessions. Participants meeting this threshold will be classified as adherent.
    • Retention rate: proportion of participants who complete the 6-month intervention period. A dropout rate <20% will be considered acceptable. Reasons for dropout will be recorded.

Secondary outcomes

  1. Feasibility of dementia risk communication and counseling

    Time frame: 6 months

    Feasibility will be assessed by uptake and completion rates (%) of the risk communication and counseling process.

  2. Psychological impact of risk communication: post-traumatic stress symptoms

    Time frame: 6 months

    Psychological impact will be assessed using the Impact of Events Scale-Revised (IES-R). Scale ranges from 0 to 88, with a higher score indicating greater post-traumatic stress symptoms.

  3. Psychological impact of risk communication: anxiety

    Time frame: 6 months

    Anxiety will be assessed using the Hospital Anxiety and Depression Scale, anxiety subscale (HADS-A). Scale ranges from 0 to 21. A score higher than 8 is taken as threshold for clinically relevant anxiety. A higher score represents a higher degree of anxiety.

  4. Psychological impact of risk communication: depressive symptoms

    Time frame: 6 months

    Depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale, depression subscale (HADS-D). Scale ranges from 0 to 21. A score higher than 8 is taken as threshold for clinically relevant depressive symptoms. A higher score represents a higher degree of depression.

  5. Psychological impact of risk communication: situational anxiety

    Time frame: 6 months

    Situational anxiety will be assessed using the State-Trait Anxiety Inventory, state subscale (STAI-S). Scale ranges from 20 to 80, with a higher score corresponding to a higher degree of situational anxiety.

  6. Change in lifestyle-related dementia risk (LIBRA index)

    Time frame: Baseline to 6 months

    Change in modifiable dementia risk factors will be assessed using a modified Lifestyle for Brain Health (LIBRA) index score based on weighted z-scores of continuous risk factor measures, which is sensitive to changes over time.

    The LIBRA score ranges between -5.9 and 12.7 (Schiepers et al., 2018; PMID: 28247500), with a higher score relating to a higher risk of developing dementia.

  7. Change in cognitive performance

    Time frame: Baseline to 6 months

    Cognitive performance will be assessed using standardized and digital cognitive tests to evaluate changes over time between intervention and control groups.

Other outcomes

  1. Prevalence of modifiable and biological dementia risk factors

    Time frame: Baseline

    Baseline characterization of modifiable risk factors and biological markers

  2. Cognitive Performance Score as a Function of LIBRA Dementia Risk Score

    Time frame: Baseline to 6 months

    Exploratory analysis of the association between LIBRA dementia risk score and cognitive performance assessed using conventional and digital cognitive tests. The association will be evaluated using regression models.

  3. Cognitive Performance Score as a Function of Plasma p-tau217 Concentration

    Time frame: Baseline to 6 months

    Exploratory analysis of the association between plasma p-tau217 concentration and cognitive performance assessed using conventional and digital cognitive tests. The association will be evaluated using regression models.

Study contacts

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

Oriol Grau Rivera

CONTACT

[email protected]

+34 933 26 31 90

Sponsors and collaborators

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Other

Collaborators

  • Hospital del Mar
  • Hospital del Mar Research Institute

Registry information

Official study title

Implementation of a Brain Health Service for Personalized Stratification and Prevention of Dementia Risk: The B-HEALTH Project

Acronym: B-HEALTH

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 13, 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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