Overview
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.
Description
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.
Eligibility
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.
