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MCITHINK-SHARPNCT07612800

Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention

A study testing BLAZE (Brain health Lifestyle Action with personaliZed Engagement) in people with MCI and Dementia, run by Alexandra Hospital at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate whether an AI-powered digital brain health coaching intervention can improve modifiable brain health risk factors in community-dwelling adults aged 40 and above in Singapore. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
MCI, Dementia
What is being tested?
BLAZE (Brain health Lifestyle Action with personaliZed Engagement)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteSingapore
Study dates
1 Sep 2026to 31 Dec 2029
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Community-dwelling adults
  • Aged 40 years and above at time of recruitment
  • Able to use a smartphone and smartphone applications
  • Able to provide written informed consent

Who cannot join

  • Been diagnosed wotj dementia, neurocognitive disorder or any major psychiatric illness
  • Have severe sensory or physical disability precluding usage of the application
  • Terminal illness or expected survival of less than 12 months at point of recruitment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore1 site
  • Alexandra Hospital

    Singapore, Singapore

    Dr Li Feng Tan, (65)85018320 ext. +65, ah_brainhealth@nuhs.edu.sg

Other trials in Singapore

About this study

Official title: Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention (THINK-SHARP)

The goal of this clinical trial is to evaluate whether an AI-powered digital brain health coaching intervention can improve modifiable brain health risk factors in community-dwelling adults aged 40 and above in Singapore.

The main question it aims to answer is: does the use of BLAZE, an AI-powered digital brain health coaching intervention, lead to a greater improvement in Brain Care Score (BCS) compared to usual care at 6 months?

Read more

Researchers will compare participants receiving BLAZE to those receiving usual care (waitlist control) to see if BLAZE leads to greater improvements in brain health risk factors, behavioural outcomes, quality of life, and cost-effectiveness.

Participants will:

  • Be randomly assigned to either receive BLAZE immediately for 12 months or be placed on a waitlist receiving usual care for the first 6 months before receiving BLAZE for a further 6 months
  • Complete a series of assessments at baseline, 6 months, and 12 months including the Brain Care Score, physical function tests, cognitive assessments, quality of life measures, and lifestyle behaviour questionnaires
  • If assigned to the intervention group, interact with BLAZE via a WhatsApp-based platform that delivers personalised brain health recommendations, behavioural nudges, educational content, and goal-setting support based on their individual Brain Care Score profile
Read the detailed description

Dementia represents a growing public health challenge in Singapore and across the Asia-Pacific region, with prevalence projected to rise substantially as the population ages. Up to 40% of dementia risk is attributable to modifiable lifestyle factors, highlighting significant potential for prevention through targeted behavioural interventions. Despite this, translating evidence-based lifestyle recommendations into sustained behavioural change in community settings remains a significant challenge, particularly given the limited time available for personalised guidance in primary care.

The THINK-SHARP trial evaluates BLAZE (Brain health Lifestyle Action with personaliZed Engagement), a theory-driven AI-powered digital coaching intervention designed to support brain health behaviours in community-dwelling adults. BLAZE is grounded in the Capability-Opportunity-Motivation-Behaviour (COM-B) framework, a well-established behavioural science model, and is delivered via a WhatsApp-based platform integrated with a large language model (LLM). The intervention operates through four integrated modules - Assessment, Education, Nudge, and Coaching - to deliver personalised recommendations, behavioural prompts, and goal-setting support tailored to each participant's individual brain health profile.

Personalisation is driven by the Brain Care Score (BCS), a validated composite measure of modifiable physical, lifestyle, and social-emotional risk factors for brain health. BLAZE uses each participant's BCS profile to identify priority areas for behavioural change and generates adaptive, data-driven recommendations accordingly. All content is informed by a curated knowledge base developed in collaboration with neurologists and geriatricians to ensure clinical relevance and safety.

The trial employs a two-arm, waitlist-controlled randomised controlled trial (RCT) design, with 350 participants randomised 1:1 to either the immediate intervention arm or the waitlist control arm. The immediate intervention arm receives BLAZE for 12 months, while the waitlist control arm receives usual care for the first 6 months before crossing over to receive BLAZE for a further 6 months. The primary outcome is the between-group difference in BCS at 6 months. Secondary outcomes assess changes across six domains: physical function, lifestyle behaviours, self-management and health engagement, cognitive function, quality of life, and social health.

Beyond clinical effectiveness, the trial incorporates a concurrent process evaluation to assess implementation outcomes including adherence, feasibility, usability, and perceived value of the intervention. A model-based health economic evaluation will also be conducted to estimate the long-term cost-effectiveness of BLAZE from the Singapore public healthcare payer perspective. Together, these components provide a comprehensive assessment of BLAZE's potential as a scalable, behaviourally grounded approach to community brain health promotion.

This trial also contributes novel evidence on the applicability of the Brain Care Score within a Southeast Asian community-dwelling population, extending its validation beyond previously studied settings and supporting its relevance for regional brain health promotion efforts.

Conditions
MCI, Dementia
Being tested
BLAZE (Brain health Lifestyle Action with personaliZed Engagement)
Keywords
COM-B, artificial intelligence, digital health intervention, mHealth, conversational agent, large language model, Whatsapp-based intervention, Just-in-time adaptive intervention (JITAI), brain health coaching, behavioural nudging
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLAZE (Brain health Lifestyle Action with personaliZed Engagement)Behavioural

    BLAZE is an AI-powered digital brain health coaching intervention delivered via a WhatsApp-based platform integrated with a large language model (LLM). Grounded in the COM-B behavioural framework, BLAZE operates through four integrated modules - Assessment, Education, Nudge, and Coaching - to deliver personalised recommendations, behavioural nudges, educational content, and goal-setting support. Personalisation is driven by each participant's Brain Care Score (BCS) profile, with intervention intensity stratified according to domain-specific scores. All content is informed by a curated knowledge base developed in collaboration with neurologists and geriatricians

Study groups in NCT07612800
Study groupRoleWhat they receive
Waitlist ControlOtherParticipants assigned to the waitlist control arm will receive usual care for the first 6 months of the study, consisting of standard educational materials on brain health. Following the 6-month assessment, waitlist control participants will receive full access to BLAZE for a further 6 months (months 6-12), identical to the intervention described in the immediate intervention arm.
Receives: Behavioral: BLAZE (Brain health Lifestyle Action with personaliZed Engagement)
BLAZE InterventionActive comparatorParticipants assigned to the immediate intervention arm will receive access to BLAZE (Brain health Lifestyle Action with personaliZed Engagement) for 12 months.
Receives: Behavioral: BLAZE (Brain health Lifestyle Action with personaliZed Engagement)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brain Care Score

    To evaluate whether the AI-powered Brain Health Coach, BLAZE, improves BCS in community-dwelling adults versus usual care.

    Measured: 12 months

Secondary outcomes (13)
  1. NHG Healthy Eating Score

    A self-reported questionnaire assessing dietary habits aligned with brain health recommendations. Scores range from 0 to 100, with higher scores indicating healthier dietary behaviours. Improvement in score reflects adoption of healthier eating patterns across domains targeted by the intervention.

    Measured: 12 months

  2. EuroQol-5 (EQ-5D)

    A standardised measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a scale of 1 (no problems) to 5 (extreme problems/unable to perform), generating a health utility index score where higher values indicate better health-related quality of life. Participants also rate their overall health on a Visual Analogue Scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: 12 months

  3. Lawton Instrumental Activities of Daily Living (IADL)

    A self-reported measure assessing the ability to perform complex daily tasks such as managing finances, using transportation, preparing meals, and using the telephone. Scores range from 0 to 8, with higher scores indicating greater functional independence. This measure monitors maintenance of functional independence in community-dwelling adults over the course of the study.

    Measured: 12 months

  4. Katz Index of Independence in Activities of Daily Living (ADL)

    A measure assessing independence in six basic daily activities: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored as independent (1) or dependent (0), yielding a total score of 0 to 6, where higher scores indicate greater independence. This measure monitors for any unexpected decline in basic functional independence during the study period.

    Measured: 12 months

  5. UCLA Loneliness Scale (UCLA-3)

    A 3-item self-reported measure assessing subjective feelings of loneliness and social isolation. Each item is rated on a scale of 1 (hardly ever) to 3 (often), with total scores ranging from 3 to 9. Higher scores indicate greater loneliness. A reduction in score reflects improved social connectedness targeted through the intervention's social engagement recommendations.

    Measured: 12 months

  6. Health Status (Self-Rated Health)

    A single-item measure asking participants to rate their overall health on a scale of 1 (excellent) to 5 (poor), or alternatively using a 5-point scale from poor to excellent depending on the version used. Higher scores on the favourable end of the scale indicate better perceived health status. This measure captures overall perceived wellbeing as a downstream indicator of sustained lifestyle behaviour change.

    Measured: 12 months

  7. Lubben Social Network Scale (LSNS-6)

    A 6-item self-reported measure assessing the size and frequency of a participant's social network, including family and friend contacts. Scores range from 0 to 30, with higher scores indicating stronger social networks. A score below 12 is considered indicative of social isolation risk. Improvement in score reflects strengthened social connections targeted through the intervention's social health domain recommendations.

    Measured: 12 months

  8. Chair Stand Test

    An objective performance-based measure of lower body strength and physical function. Participants are timed completing five sit-to-stand repetitions from a chair without using their arms. Faster completion times indicate better lower body strength and physical function. Improvement in performance reflects increased physical activity and strength targeted through the intervention's physical health recommendations.

    Measured: 12 months

  9. Grip Strength

    An objective measure of overall muscular strength assessed using a handheld dynamometer. Results are recorded in kilograms, with higher values indicating greater muscular strength. Improvement in grip strength reflects sustained engagement in physical activity behaviours targeted through the intervention.

    Measured: 12 months

  10. Adapted Dementia Knowledge and Attitudes (14-item)

    A 14-item adapted questionnaire assessing knowledge of dementia risk factors, symptoms, and prevention strategies, as well as attitudes towards dementia. Six items were adapted from the validated Dementia Knowledge and Attitudes Scale (DKAS) and ten items from a comparative analysis of dementia health literacy in Singapore. Higher scores indicate greater dementia knowledge and more positive attitudes towards dementia.

    Measured: 12 months

  11. Partners in Health Scale (PIH)

    A 12-item self-reported measure assessing self-management capacity across four domains: knowledge of condition, adherence to treatment, recognition and management of symptoms, and coping. Each item is rated on a scale of 0 to 8, with total scores ranging from 0 to 96. Higher scores indicate greater self-management capacity. Improvement in score reflects the intervention's coaching module supporting independent brain health management.

    Measured: 12 months

  12. Rapid Assessment of Physical Activity (RAPA)

    A self-reported questionnaire assessing aerobic physical activity levels and strength and flexibility behaviours. The aerobic component is scored from 1 to 7, where scores of 1-4 indicate sub-optimal activity levels and scores of 5-7 indicate recommended levels of moderate to vigorous physical activity. The strength and flexibility component is scored from 0 to 2. Higher scores across both components indicate more active lifestyle behaviours. Improvement reflects the intervention's physical activity nudges and goal-setting support.

    Measured: 12 months

  13. Montreal Cognitive Assessment (MoCA)

    A brief 30-item cognitive screening tool assessing multiple cognitive domains including memory, attention, language, visuospatial ability, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is considered within the normal range. This measure provides a baseline cognitive profile and enables monitoring of any meaningful change in global cognitive function during the study period.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
This study is a two-arm, parallel-group randomised controlled trial with a 1:1 allocation ratio. Following recruitment, participants will be randomly allocated to either the intervention or control group. The intervention group will receive personalised brain health coaching through the AI-coach for 12 months, while the control group will receive standard care, followed by access to the AI-coach for the subsequent 6 months. This delayed introduction of the AI-coach allows comparison of intervention effectiveness at 6 months as the primary outcome timepoint, with secondary assessments at 12 months to evaluate sustainability of change and within-group effects
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612800
Sponsor's protocol ID
2025-1562
Other IDs
NICCOG2024-0027
Acronym
THINK-SHARP
Status last verified
May 2026
First submitted
21 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: A decision on whether and how individual participant data will be shared with external researchers has not yet been made. Plans for data sharing will be determined following completion of the trial and will be guided by applicable institutional policies, ethical considerations, and data governance requirements in Singapore.

Publications

  • Kashdan TB, Disabato DJ, Goodman FR, et al. The Five-Dimensional Curiosity Scale Revised (5DCR): Briefer subscales while separating overt and covert social curiosity. Personality and Individual Differences 2020;157:109836.

  • Virginia B, Victoria C. Using thematic analysis in psychology. Qualitative Research in Psychology 2006;3(2):77--101

  • Guest G, Bunce A, Johnson L. How Many Interviews Are Enough?:An Experiment with Data Saturation and Variability. Field Methods 2006;18(1):59-82

  • Lubben JE. Assessing social networks among elderly populations. Family & Community Health 1988;11(3):42-52.

  • Petkov J, Harvey P, Battersby M. The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010 Sep;19(7):1079-85. doi: 10.1007/s11136-010-9661-1. Epub 2010 May 1.

    PubMed 20437206
  • Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.

    PubMed 23614330
  • Matthews JA, Matthews S, Faries MD, Wolever RQ. Supporting Sustainable Health Behavior Change: The Whole is Greater Than the Sum of Its Parts. Mayo Clin Proc Innov Qual Outcomes. 2024 May 18;8(3):263-275. doi: 10.1016/j.mayocpiqo.2023.10.002. eCollection 2024 Jun.

    PubMed 38807973
  • Bowen PG, Jones CD, Myers T, Martin R, Knight A, Azuero A, Smith T, Lancaster C, Brewer M, Davuluri S, Delaney E, Asif I, Lazar RM. Implementing brain health strategies in primary care: methods and baseline findings from the BHAM registry. Arch Public Health. 2025 Dec 29;83(1):306. doi: 10.1186/s13690-025-01768-0.

    PubMed 41462348
  • Tan BY, Tan LF, Rosand J. Shifting the needle in cognitive health: urgent action on modifiable risk factors to prevent dementia in Singapore. Singapore Med J. 2025 Mar 7. doi: 10.4103/singaporemedj.SMJ-2024-216. Online ahead of print. No abstract available.

    PubMed 40125579
  • Shelkey M, Wallace M. Katz Index of Independence in Activities of Daily Living. J Gerontol Nurs. 1999 Mar;25(3):8-9. doi: 10.3928/0098-9134-19990301-05. No abstract available.

    PubMed 10362969
  • Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score--an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27.

    PubMed 25345554
  • de Miquel C, Haro JM, van der Feltz-Cornelis CM, Ortiz-Tallo A, Chen T, Sinokki M, Naumanen P, Olaya B, Lima RA. Differential attrition and engagement in randomized controlled trials of occupational mental health interventions in person and online: A systematic review and meta-analysis. Scand J Work Environ Health. 2024 Dec 1;50(8):588-601. doi: 10.5271/sjweh.4173. Epub 2024 Jul 29.

    PubMed 39072699
  • Dhinagaran DA, Sathish T, Soong A, Theng YL, Best J, Tudor Car L. Conversational Agent for Healthy Lifestyle Behavior Change: Web-Based Feasibility Study. JMIR Form Res. 2021 Dec 3;5(12):e27956. doi: 10.2196/27956.

    PubMed 34870611
  • Maher CA, Davis CR, Curtis RG, Short CE, Murphy KJ. A Physical Activity and Diet Program Delivered by Artificially Intelligent Virtual Health Coach: Proof-of-Concept Study. JMIR Mhealth Uhealth. 2020 Jul 10;8(7):e17558. doi: 10.2196/17558.

    PubMed 32673246
  • Loughnane C, Laiti J, O'Donovan R, Dunne PJ. Systematic review exploring human, AI, and hybrid health coaching in digital health interventions: trends, engagement, and lifestyle outcomes. Front Digit Health. 2025 Apr 24;7:1536416. doi: 10.3389/fdgth.2025.1536416. eCollection 2025.

    PubMed 40343215

Questions about this trial

What is this clinical trial studying?

A study testing BLAZE (Brain health Lifestyle Action with personaliZed Engagement) in people with MCI and Dementia, run by Alexandra Hospital at 1 site in Singapore.

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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 May 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 Singapore. 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 Dr Li Feng Tan ((65)85018320 ext. +65, ah_brainhealth@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Care Score (time frame: 12 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 NCT07612800, which also lists 42 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 29 May 2026.

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