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NOT YET RECRUITING
NCT07698431
NA

Personalized Brain Health Service and Dementia Prevention

Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-09-01

Completion Date

2028-08-01

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

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).

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

Locations (1)

Fundació Pasqual Maragall

Barcelona, Catalonia, Spain