Personalized Brain Health Service and Dementia Prevention (B-HEALTH)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subjective Cognitive Decline (SCD)
• Intervention / Treatment: Behavioral: Lifestyle Recommendations and Counseling; Behavioral: Multimodal Lifestyle Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oriol Grau Rivera; Phone Number: +34 933 26 31 90; Email: ograu@barcelonabeta.org

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08005
      • Fundació Pasqual Maragall
      • Contact: Anna Soteras Prat; Phone Number: +34 933 26 31 90; Email: asoteras@barcelonabeta.org
      • Principal Investigator: Oriol Grau-Rivera, PhD
      • Sub-Investigator: Ana Fernández-Arcos, PhD
      • Sub-Investigator: Natàlia Soldevila Domènech, PhD
      • Sub-Investigator: Andrea Horta-Barba, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Participants in the control arm will receive general recommendations on dementia risk reduction at the beginning of the study, reflecting standard preventive advice. They will have access to a mobile application providing information on dementia risk factors; however, the application will not include personalized feedback or interactive intervention components. Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep.	Behavioral: Lifestyle Recommendations and Counseling; 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
Experimental: Personalized intervention; Participants in the experimental arm will receive a 6-month personalized, multimodal intervention tailored to their individual dementia risk profile. The intervention includes components targeting key domains of brain health, including nutrition, physical activity, cognitive training, and psychoeducation, with the intensity and combination of components adapted according to risk level. Participants will have access to a mobile application providing personalized feedback on lifestyle behaviors and interactive support to promote adherence to the intervention. Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep.	Behavioral: Multimodal Lifestyle Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the multimodal intervention	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of dementia risk communication and counseling	Feasibility will be assessed by uptake and completion rates (%) of the risk communication and counseling process.	6 months
Psychological impact of risk communication: post-traumatic stress symptoms	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.	6 months
Psychological impact of risk communication: anxiety	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.	6 months
Psychological impact of risk communication: depressive symptoms	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.	6 months
Psychological impact of risk communication: situational anxiety	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 months
Change in lifestyle-related dementia risk (LIBRA index)	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.	Baseline to 6 months
Change in cognitive performance	Cognitive performance will be assessed using standardized and digital cognitive tests to evaluate changes over time between intervention and control groups.	Baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of modifiable and biological dementia risk factors	Baseline characterization of modifiable risk factors and biological markers	Baseline
Cognitive Performance Score as a Function of LIBRA Dementia Risk Score	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.	Baseline to 6 months
Cognitive Performance Score as a Function of Plasma p-tau217 Concentration	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Collaborators: Hospital del Mar; Hospital del Mar Research Institute

Publications and helpful links

General Publications

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
• Galvin JE. Prevention of Alzheimer's Disease: Lessons Learned and Applied. J Am Geriatr Soc. 2017 Oct;65(10):2128-2133. doi: 10.1111/jgs.14997. Epub 2017 Aug 2.
• Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashemi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.
• Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
• Jessen F, Amariglio RE, Buckley RF, van der Flier WM, Han Y, Molinuevo JL, Rabin L, Rentz DM, Rodriguez-Gomez O, Saykin AJ, Sikkes SAM, Smart CM, Wolfsgruber S, Wagner M. The characterisation of subjective cognitive decline. Lancet Neurol. 2020 Mar;19(3):271-278. doi: 10.1016/S1474-4422(19)30368-0. Epub 2020 Jan 17.
• Rosenau C, Kohler S, van Boxtel M, Tange H, Deckers K. Validation of the Updated "LIfestyle for BRAin health" (LIBRA) Index in the English Longitudinal Study of Ageing and Maastricht Aging Study. J Alzheimers Dis. 2024;101(4):1237-1248. doi: 10.3233/JAD-240666.
• Forcano L, Fauria K, Soldevila-Domenech N, Minguillon C, Lorenzo T, Cuenca-Royo A, Menezes-Cabral S, Pizarro N, Boronat A, Molinuevo JL, de la Torre R; PENSA Study Groupǂ. Prevention of cognitive decline in subjective cognitive decline APOE epsilon4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimers Dement (N Y). 2021 Mar 31;7(1):e12155. doi: 10.1002/trc2.12155. eCollection 2021.
• Vos SJB, van Boxtel MPJ, Schiepers OJG, Deckers K, de Vugt M, Carriere I, Dartigues JF, Peres K, Artero S, Ritchie K, Galluzzo L, Scafato E, Frisoni GB, Huisman M, Comijs HC, Sacuiu SF, Skoog I, Irving K, O'Donnell CA, Verhey FRJ, Visser PJ, Kohler S. Modifiable Risk Factors for Prevention of Dementia in Midlife, Late Life and the Oldest-Old: Validation of the LIBRA Index. J Alzheimers Dis. 2017;58(2):537-547. doi: 10.3233/JAD-161208.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's disease; mHealth; Risk stratification; eHealth; non-pharmacological; Lifestyle factors; Dementia prevention; Multimodal intervention; Subjective cognitive decline (SCD); Dementia risk communication; Brain Health Service; Personalized prevention plan; ptau-217
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: B-HEALTH_BBRC2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No