Subjective Cognitive Decline (SCD)B-HEALTHNCT07698431
Personalized Brain Health Service and Dementia Prevention
A study testing Multimodal Lifestyle Intervention and Lifestyle Recommendations and Counseling in people with Subjective Cognitive Decline (SCD), run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Subjective Cognitive Decline (SCD)
- What is being tested?
- Multimodal Lifestyle Intervention and Lifestyle Recommendations and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundació Pasqual Maragall
Barcelona, Catalonia, 08005
Anna Soteras Prat, +34 933 26 31 90, asoteras@barcelonabeta.org
Oriol Grau-Rivera, PhD
About this study
Official title: Implementation of a Brain Health Service for Personalized Stratification and Prevention of Dementia Risk: The B-HEALTH Project
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.
Read more
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.
Read the 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.
- Conditions
- Subjective Cognitive Decline (SCD)
- Being tested
- Multimodal Lifestyle Intervention, Lifestyle Recommendations and Counseling
- 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
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Lifestyle InterventionBehavioural
Also called Non-pharmacological 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).
Lifestyle Recommendations and CounselingBehavioural
Also called General Lifestyle Recommendations
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in the control arm will receive general recommendations on dementia risk reduction at the beginning of the study, reflecting standard preventive advice.
They will have access to a mobile application providing information on dementia risk factors; however, the application will not include personalized feedback or interactive intervention components.
Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep. Receives: Behavioral: Lifestyle Recommendations and Counseling |
| Personalized intervention | Experimental | Participants in the experimental arm will receive a 6-month personalized, multimodal intervention tailored to their individual dementia risk profile.
The intervention includes components targeting key domains of brain health, including nutrition, physical activity, cognitive training, and psychoeducation, with the intensity and combination of components adapted according to risk level.
Participants will have access to a mobile application providing personalized feedback on lifestyle behaviors and interactive support to promote adherence to the intervention.
Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep. Receives: Behavioral: Multimodal Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the multimodal intervention
Feasibility will be assessed using recruitment, adherence, and retention rates:
- Recruitment rate: proportion of participants randomized among those eligible and invited to participate. A rate ≥50% will be considered successful.
- 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.
- 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.
Measured: 6 months
Secondary outcomes (7)
Feasibility of dementia risk communication and counseling
Feasibility will be assessed by uptake and completion rates (%) of the risk communication and counseling process.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Psychological impact of risk communication: situational anxiety
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.
Measured: 6 months
Change in lifestyle-related dementia risk (LIBRA index)
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.
Measured: Baseline to 6 months
Change in cognitive performance
Cognitive performance will be assessed using standardized and digital cognitive tests to evaluate changes over time between intervention and control groups.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar, Hospital del Mar Research Institute (IMIM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698431
- Sponsor's protocol ID
- B-HEALTH_BBRC2025
- Acronym
- B-HEALTH
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenau C, Kohler S, van Boxtel M, Tange H, Deckers K. Validation of the Updated "LIfestyle for BRAin health" (LIBRA) Index in the English Longitudinal Study of Ageing and Maastricht Aging Study. J Alzheimers Dis. 2024;101(4):1237-1248. doi: 10.3233/JAD-240666.
PubMed 39302374Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashemi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.
PubMed 26594639Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
PubMed 25771249Galvin JE. Prevention of Alzheimer's Disease: Lessons Learned and Applied. J Am Geriatr Soc. 2017 Oct;65(10):2128-2133. doi: 10.1111/jgs.14997. Epub 2017 Aug 2.
PubMed 28766695Forcano L, Fauria K, Soldevila-Domenech N, Minguillon C, Lorenzo T, Cuenca-Royo A, Menezes-Cabral S, Pizarro N, Boronat A, Molinuevo JL, de la Torre R; PENSA Study Groupǂ. Prevention of cognitive decline in subjective cognitive decline APOE epsilon4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimers Dement (N Y). 2021 Mar 31;7(1):e12155. doi: 10.1002/trc2.12155. eCollection 2021.
PubMed 33816762Vos SJB, van Boxtel MPJ, Schiepers OJG, Deckers K, de Vugt M, Carriere I, Dartigues JF, Peres K, Artero S, Ritchie K, Galluzzo L, Scafato E, Frisoni GB, Huisman M, Comijs HC, Sacuiu SF, Skoog I, Irving K, O'Donnell CA, Verhey FRJ, Visser PJ, Kohler S. Modifiable Risk Factors for Prevention of Dementia in Midlife, Late Life and the Oldest-Old: Validation of the LIBRA Index. J Alzheimers Dis. 2017;58(2):537-547. doi: 10.3233/JAD-161208.
PubMed 28453475Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
PubMed 39096926Jessen F, Amariglio RE, Buckley RF, van der Flier WM, Han Y, Molinuevo JL, Rabin L, Rentz DM, Rodriguez-Gomez O, Saykin AJ, Sikkes SAM, Smart CM, Wolfsgruber S, Wagner M. The characterisation of subjective cognitive decline. Lancet Neurol. 2020 Mar;19(3):271-278. doi: 10.1016/S1474-4422(19)30368-0. Epub 2020 Jan 17.
PubMed 31958406
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Brain Health Service for Personalized Stratification and Prevention of Dementia Risk: The B-HEALTH Project
- ClinicalTrials.gov ID
- NCT07698431
- Acronym / sponsor ID
- B-HEALTH / B-HEALTH_BBRC2025
- Conditions
- Subjective Cognitive Decline (SCD)
- Keywords
- Dementia prevention, Alzheimer's disease, Subjective cognitive decline (SCD), Dementia risk communication, Brain Health Service, Personalized prevention plan, Multimodal intervention, Lifestyle factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Collaborators
- Hospital del Mar, Hospital del Mar Research Institute (IMIM)
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Lifestyle Recommendations and CounselingParticipants in the control arm will receive general recommendations on dementia risk reduction at the beginning of the study, reflecting standard preventive advice. They will have access to a mobile application providing information on dementia risk factors; however, the application will not include personalized feedback or interactive intervention components. Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep. |
| Personalized intervention | Experimental | Behavioral: Multimodal Lifestyle InterventionParticipants in the experimental arm will receive a 6-month personalized, multimodal intervention tailored to their individual dementia risk profile. The intervention includes components targeting key domains of brain health, including nutrition, physical activity, cognitive training, and psychoeducation, with the intensity and combination of components adapted according to risk level. Participants will have access to a mobile application providing personalized feedback on lifestyle behaviors and interactive support to promote adherence to the intervention. Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Lifestyle InterventionAlso: Non-pharmacological interventionThe 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). | Behavioural | Personalized intervention |
| Lifestyle Recommendations and CounselingAlso: General Lifestyle RecommendationsStandard 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 | Behavioural | Control |
Primary outcome
Feasibility of the multimodal intervention
Time frame: 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.
7 secondary outcomes
Feasibility of dementia risk communication and counseling
Time frame: 6 months
Psychological impact of risk communication: post-traumatic stress symptoms
Time frame: 6 months
Psychological impact of risk communication: anxiety
Time frame: 6 months
Psychological impact of risk communication: depressive symptoms
Time frame: 6 months
Psychological impact of risk communication: situational anxiety
Time frame: 6 months
Change in lifestyle-related dementia risk (LIBRA index)
Time frame: Baseline to 6 months
Change in cognitive performance
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 39302374Rosenau C, Kohler S, van Boxtel M, Tange H, Deckers K. Validation of the Updated "LIfestyle for BRAin health" (LIBRA) Index in the English Longitudinal Study of Ageing and Maastricht Aging Study. J Alzheimers Dis. 2024;101(4):1237-1248. doi: 10.3233/JAD-240666.
- Background: PubMed 26594639Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashemi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.
- Background: PubMed 25771249Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
- Background: PubMed 28766695Galvin JE. Prevention of Alzheimer's Disease: Lessons Learned and Applied. J Am Geriatr Soc. 2017 Oct;65(10):2128-2133. doi: 10.1111/jgs.14997. Epub 2017 Aug 2.
- Background: PubMed 33816762Forcano L, Fauria K, Soldevila-Domenech N, Minguillon C, Lorenzo T, Cuenca-Royo A, Menezes-Cabral S, Pizarro N, Boronat A, Molinuevo JL, de la Torre R; PENSA Study Groupǂ. Prevention of cognitive decline in subjective cognitive decline APOE epsilon4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimers Dement (N Y). 2021 Mar 31;7(1):e12155. doi: 10.1002/trc2.12155. eCollection 2021.
- Background: PubMed 28453475Vos SJB, van Boxtel MPJ, Schiepers OJG, Deckers K, de Vugt M, Carriere I, Dartigues JF, Peres K, Artero S, Ritchie K, Galluzzo L, Scafato E, Frisoni GB, Huisman M, Comijs HC, Sacuiu SF, Skoog I, Irving K, O'Donnell CA, Verhey FRJ, Visser PJ, Kohler S. Modifiable Risk Factors for Prevention of Dementia in Midlife, Late Life and the Oldest-Old: Validation of the LIBRA Index. J Alzheimers Dis. 2017;58(2):537-547. doi: 10.3233/JAD-161208.
- Background: PubMed 39096926Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
- Background: PubMed 31958406Jessen F, Amariglio RE, Buckley RF, van der Flier WM, Han Y, Molinuevo JL, Rabin L, Rentz DM, Rodriguez-Gomez O, Saykin AJ, Sikkes SAM, Smart CM, Wolfsgruber S, Wagner M. The characterisation of subjective cognitive decline. Lancet Neurol. 2020 Mar;19(3):271-278. doi: 10.1016/S1474-4422(19)30368-0. Epub 2020 Jan 17.
- Individual participant dataSharing planned: No
Related trials for Subjective Cognitive Decline (SCD)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Chinese Classics Recitation Training in Subjective Cognitive Decline
Subjective Cognitive Decline (SCD), Subjective Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Lifestyle Intervention and Lifestyle Recommendations and Counseling in people with Subjective Cognitive Decline (SCD), run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriol Grau Rivera (+34 933 26 31 90, ograu@barcelonabeta.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the multimodal intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698431, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.