Personalized Brain Health Service and Dementia Prevention

NCT07698431 | Not Yet Recruiting

• 1 other identifier: B-HEALTH_BBRC2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subjective Cognitive Decline (SCD)

Keywords

Dementia prevention; Alzheimer's disease; Subjective cognitive decline (SCD); Dementia risk communication; Brain Health Service; Personalized prevention plan; Multimodal intervention; Lifestyle factors; Risk stratification; eHealth; ptau-217; mHealth; non-pharmacological

Outcome Measures

Primary Outcomes (1)

• Feasibility of the multimodal intervention

  Feasibility will be assessed using recruitment, adherence, and retention rates: 1. Recruitment rate: proportion of participants randomized among those eligible and invited to participate. A rate ≥50% will be considered successful. 2. 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. 3. 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 Outcomes (7)

• Feasibility of dementia risk communication and counseling

  6 months

• Psychological impact of risk communication: post-traumatic stress symptoms

  6 months

• Psychological impact of risk communication: anxiety

  6 months

• Psychological impact of risk communication: depressive symptoms

  6 months

• Psychological impact of risk communication: situational anxiety

  6 months

Other Outcomes (3)

• Prevalence of modifiable and biological dementia risk factors

  Baseline

• Cognitive Performance Score as a Function of LIBRA Dementia Risk Score

  Baseline to 6 months

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

  Baseline to 6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Personalized intervention

EXPERIMENTAL

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

Interventions

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).

Also known as: Non-pharmacological intervention

Personalized 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

Also known as: General Lifestyle Recommendations

Control

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Mar: collaborator
• Hospital del Mar Research Institute: collaborator
• Barcelonabeta Brain Research Center, Pasqual Maragall Foundation: lead

Study Sites (1)

Fundació Pasqual Maragall

Barcelona, Catalonia, 08005, Spain

Location

Related Publications (8)

• 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.

  PMID: 39302374 BACKGROUND

• 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.

  PMID: 26594639 BACKGROUND

• 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.

  PMID: 25771249 BACKGROUND

• 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.

  PMID: 28766695 BACKGROUND

• 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.

  PMID: 33816762 BACKGROUND

• 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.

  PMID: 28453475 BACKGROUND

• 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.

  PMID: 39096926 BACKGROUND

• 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.

  PMID: 31958406 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Counseling

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Oriol Grau Rivera

CONTACT

+34 933 26 31 90; ograu@barcelonabeta.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Nurses, neuropsychologysts and imaging experts performing the study visits will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be stratified into three subgroups (low, intermediate, and high risk) based on their individual dementia risk profile, which incorporates both modifiable and non-modifiable risk factors. Participants will then be randomized into either an intervention group or a control group, with group allocation balanced across risk subgroups. The intervention consists of a 6-month personalized, multimodal program tailored to each risk subgroup, with increasing intensity and level of support for participants at higher risk. Participants in the control group will receive general dementia prevention advice but will not have access to the personalized intervention during the 6-month study period.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)