Subjective Cognitive Decline (SCD)
Conditions
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
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.
Detailed description
The scientific literature highlights the potential of dementia prevention, with studies showing decreasing incidence rates in developed countries and clinical trials demonstrating the benefits of multimodal lifestyle interventions. However, translating this evidence into clinical practice requires further scientific validation. Subjective Cognitive Decline (SCD) refers to individuals who report cognitive complaints despite normal performance on standardized cognitive tests. This population is increasingly represented in memory clinics, accounting for approximately 20-30% of consultations in some European centers. Individuals with SCD have an increased risk of developing mild cognitive impairment and dementia compared with those without cognitive complaints, and SCD may represent an early clinical manifestation of neurodegenerative disease. However, current clinical pathways are primarily oriented toward diagnosis and management of established impairment, and individuals with SCD are often discharged without access to personalized risk assessment or prevention strategies. Brain Health Services (BHS) have been proposed as a new clinical model to address this gap. These services aim to provide comprehensive dementia risk assessment, individualized risk communication, and tailored prevention strategies. Core components include the evaluation of modifiable and biological risk factors, the use of validated algorithms for risk stratification, structured and ethically sound risk communication, and personalized interventions targeting multiple domains of brain health. The B-HEALTH project is a proof-of-concept longitudinal study designed to evaluate the feasibility and preliminary impact of implementing a Brain Health Service in a real-world clinical setting. A total of 120 participants with SCD will be recruited from the Cognitive Disorders Unit at Hospital del Mar and randomly assigned to either an intervention group or a control group receiving general dementia prevention advice. Participants will undergo a comprehensive risk assessment integrating clinical, lifestyle, and biological information. Individual dementia risk profiles will be generated using validated risk scores (e.g., LIBRA index) and blood-based markers of Alzheimer's Disease (AD) pathology (ptau-217). Participants in the intervention group will be offered a structured Dementia Risk Communication and Counseling process and may choose whether or not to receive their individualized risk estimate. Following this, participants in the intervention group will receive a 6-month multimodal prevention program tailored to their level of dementia risk. The intervention targets physical activity, nutrition, sleep, cognitive stimulation, psychoeducation, and social engagement. The intensity of the intervention will be adapted according to individual risk level. The program combines digital health (eHealth) tools with in-person components. These include a mobile application and a fitness tracker for continuous monitoring and feedback on lifestyle behaviours and sleep, digital cognitive assessments, and computerized cognitive training. The primary objective of the study is to evaluate the feasibility of implementing this personalized risk stratification and prevention model in a clinical setting, including recruitment, adherence, and retention. Secondary objectives include assessing the psychological impact and acceptability of dementia risk communication, and exploring the effects of the multimodal intervention on lifestyle behaviors and cognitive outcomes. Additional exploratory analyses will examine associations between modifiable and biological risk factors and longitudinal cognitive performance.
Interventions
BEHAVIORALMultimodal 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).
BEHAVIORALLifestyle 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
Sponsors
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Hospital del Mar
Hospital del Mar Research Institute (IMIM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Nurses, neuropsychologysts and imaging experts performing the study visits will be blinded.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the multimodal intervention | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of dementia risk communication and counseling | 6 months | 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 | 6 months | 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 | 6 months | 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 | 6 months | 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. |
| Psychological impact of risk communication: situational anxiety | 6 months | Situational anxiety will be assessed using the State-Trait Anxiety Inventory, state subscale (STAI-S). Scale ranges from 20 to 80, with a higher score corresponding to a higher degree of situational anxiety. |
| Change in lifestyle-related dementia risk (LIBRA index) | Baseline to 6 months | Change in modifiable dementia risk factors will be assessed using a modified Lifestyle for Brain Health (LIBRA) index score based on weighted z-scores of continuous risk factor measures, which is sensitive to changes over time. The LIBRA score ranges between -5.9 and 12.7 (Schiepers et al., 2018; PMID: 28247500), with a higher score relating to a higher risk of developing dementia. |
| Change in cognitive performance | Baseline to 6 months | Cognitive performance will be assessed using standardized and digital cognitive tests to evaluate changes over time between intervention and control groups. |
Countries
Spain
Contacts
CONTACTOriol Grau Rivera
Outcome results
None listed