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.
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.
Objective cognitive impairment.
Clinically relevant neurological disorders.
Major psychiatric disorders.
History of drug/alcohol abuse.
Parallel
Multimodal Lifestyle Intervention
BehavioralThe 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).
Lifestyle Recommendations and Counseling
BehavioralStandard 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
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.
Feasibility of dementia risk communication and counseling
Feasibility will be assessed by uptake and completion rates (%) of the risk communication and counseling process.
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.
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.
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.
Prevalence of modifiable and biological dementia risk factors
Baseline characterization of modifiable risk factors and biological markers
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.
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.
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Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Lead sponsor
Hospital del Mar
Collaborator
Hospital del Mar Research Institute (IMIM)
Collaborator
