Personalized Brain Health Service and Dementia Prevention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorBarcelonabeta Brain Research Center, Pasqual Maragall Foundation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Objective cognitive impairment.

Clinically relevant neurological disorders.

Major psychiatric disorders.

History of drug/alcohol abuse.

Trial design

Treatments tested in this trial

  • Multimodal Lifestyle Intervention
  • Lifestyle Recommendations and Counseling

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Lead sponsor

Hospital del Mar

Collaborator

Hospital del Mar Research Institute

Collaborator