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Personalized Brain Health Service and Dementia Prevention

Study acronym: B-HEALTH
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Feb 1, 2027 → Dec 31, 2027
See other at-risk trials from Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 1, 2027 to Dec 31, 2027 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Sep 1, 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Site details revised
    • Publications: details revised at 8 of 8 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07698431
Lead Sponsor Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborators: Hospital del Mar, Hospital del Mar Research Institute (IMIM)
Conditions
(from sponsor)		 Subjective Cognitive Decline (SCD)
Related terms Alzheimer Disease
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov