DementiaNCT07531589
BrainLive Connect: Non-professional Delivered CST for People Living With Dementia
A study testing Cognitive Stimulation Therapy (CST) in people with Dementia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this mixed method study is to evaluate whether the volunteer-led Cognitive Stimulation Therapy (CST) under the BrainLive Connect programme is effective for improving cognitive function and quality of life of people living with dementia (PLwD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Cognitive Stimulation Therapy (CST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Mar 2026to 10 Nov 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PLwD: Hong Kong residents, mild to moderate dementia, either having i) a formal diagnosis, or 2) suspected dementia reported by care professionals and screened by Montreal Cognitive Assessment (MoCA).
- Family carers: self-identified as the primary carer of the PLwD.
Who cannot join
- Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
JACKY CP CHOY, Philosophy of Doctor, 39170079, cpchoy@hku.hk
Shiyu LU, PhD
About this study
Official title: BrainLive Connect: Non-professional Delivered Cognitive Stimulation Therapy for People Living With Dementia
The goal of this mixed method study is to evaluate whether the volunteer-led Cognitive Stimulation Therapy (CST) under the BrainLive Connect programme is effective for improving cognitive function and quality of life of people living with dementia (PLwD).
The main question it aims to answer are:
Read more
- Do PLwD receiving the BrainLive Connect service show better cognitive function and quality of life than those receiving usual care?
Researchers will compare BrainLive Connect service to usual care to see whether the intervention leads to better outcomes.
Participants will:
- Receive either 7 weeks of BrainLive Connect sessions delivered by trained volunteers or continue receiving usual care.
- Be assessed at baseline (T0), post-intervention (7 weeks; T1), and 1 month follow up (11 weeks; T2).
- Take part in semi-strucutred interviews post-intervention to provide feedback on implementation and areas for improvement.
Read the detailed description
The research design is a non-randomized controlled trial (nRCT), involving 260 PLwD in the experimental group (BrainLive group) who will receive 7 weeks of BrainLive Connect service, and another 260 PLwD in the control group (Care-as-usual group) who will receive usual care for comparison. Participants of the experimental group will be recruited by our partnering NGOs, and those of the control group will be from both the partnering NGOs and network of HKU. Outcomes of PLwD and their carers will be measured at three time points: intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2), to assess the lasting effects of the volunteer-led CST. During the evaluation period, participants in the control group will receive standard care and support.
The BrainLive Connect service aimed at maintaining cognitive functions, and improving quality of life (Primary outcomes); and reducing distressed behaviour, improving social functioning, reduced carer burden, improving daily functioning, and preference for ageing-in-place (Secondary outcomes).
- Conditions
- Dementia
- Being tested
- Cognitive Stimulation Therapy (CST), Usual Care
- Keywords
- Dementia, Cognitive Stimulation Therapy, Volunteer-led intervention, Quality of life, Cognitive function, BrainLive Connect, Care burden
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulation Therapy (CST)Behavioural
CST has been recognized as an effective and cost-effective intervention for individuals with mild to moderate dementia, leading to improvements in cognition and quality of life. CST is one of the few non-pharmacological interventions recommended by the National Institute for Health and Care Excellence (NICE) in their clinical guideline on dementia, as it has comparable efficacy to anti-dementia drugs. Exercise-enhanced CST is characterised by adding physical exercise into the original group CST protocol. Home2Community CST is characterized by a gradual shift of its intervention site from the participant's home to public space in their neighbourhood and then further to centre-based settings. Living CST is characterised by transferring CST into real life settings to maximise its benefits in daily functioning for independent living.
Usual CareOther
Usual care and support service for people living with dementia in community, including but not limited to, care service, psychosocial intervention (but not CST), and social activities.
| Study group | Role | What they receive |
|---|---|---|
| Non-professional delivered CST | Experimental | Participants will receive 14-session Cognitive Stimulation Therapy (CST) delivered by trained volunteers, with two sessions per week over a period of 7 weeks Receives: Behavioral: Cognitive Stimulation Therapy (CST) |
| Usual social care | Active comparator | Participants will receive usual social care and support provided by elderly care service units operated by non-governmental organisations, including but not limited to care services, psychosocial intervention, and social activites. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Possible range: 0 -70, with higher scores indicate more impairment
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Quality of Life-Alzheimer's Disease (QoL-AD)
Possible range: 13 - 52, with higher scores indicate better quality of life
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Secondary outcomes (7)
Neuropsychiatric Inventory Questionnaire (NPIQ)
Possible range: 0 - 60, with higher scores indicate higher carer distress and severity
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Social functioning in Dementia Scale (HKSF-DEM: carer rating)
Possible range: 0 - 51, with higher scores indicate better social functioning
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Care burden (Zarit Burden Interview short version, 12-item)
Possible range: 0 - 48, with higher scores indicate greater burden
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
The Lawton Instrumental Activities of Daily Living (IADL)
Possible range: 0 - 27, with higher scores indicate higher functional independence
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Preference for ageing-in place (self-developed scale)
Possible range: 1 - 5, with higher scores indicate lower preference for ageing-in place
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Preparation of ageing in-place (self-developed scale)
Possible range: 5 - 25, with higher scores indicate better preparation of ageing in place
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
The Montreal Cognitive Assessment subscale (MoCA subscale)
Possible range: 0 - 3, with higher scores indicate better language ability
Measured: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Simon K.Y.Lee Foundation, Yang Memorial Methodist Social Service, Christian Family Service Centre, Hong Kong Young Women's Christian Association
- Responsible party
- Principal investigator, Choy Chak Pui Jacky, The University of Hong Kong
- Investigators
- Shiyu LU, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531589
- Sponsor's protocol ID
- EA250765a
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be available upon request.
Publications
Groot C, Hooghiemstra AM, Raijmakers PG, van Berckel BN, Scheltens P, Scherder EJ, van der Flier WM, Ossenkoppele R. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials. Ageing Res Rev. 2016 Jan;25:13-23. doi: 10.1016/j.arr.2015.11.005. Epub 2015 Nov 28.
PubMed 26607411Knapp M, Bauer A, Wittenberg R, Comas-Herrera A, Cyhlarova E, Hu B, Jagger C, Kingston A, Patel A, Spector A, Wessel A, Wong G. What are the current and projected future cost and health-related quality of life implications of scaling up cognitive stimulation therapy? Int J Geriatr Psychiatry. 2022 Jan;37(1). doi: 10.1002/gps.5633. Epub 2021 Oct 15.
PubMed 34613622Knapp M, Thorgrimsen L, Patel A, Spector A, Hallam A, Woods B, Orrell M. Cognitive stimulation therapy for people with dementia: cost-effectiveness analysis. Br J Psychiatry. 2006 Jun;188:574-80. doi: 10.1192/bjp.bp.105.010561.
PubMed 16738349Dementia: Assessment, management and support for people living with dementia and their carers. London: National Institute for Health and Care Excellence (NICE); 2018 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK513207/
PubMed 30011160Ryan S, Brady O. Cognitive stimulation and activities of daily living for individuals with mild-to-moderate dementia: A scoping review. Br J Occup Ther. 2023 Aug;86(8):540-559. doi: 10.1177/03080226231156517. Epub 2023 Mar 15.
PubMed 40337614Toh HM, Ghazali SE, Subramaniam P. The Acceptability and Usefulness of Cognitive Stimulation Therapy for Older Adults with Dementia: A Narrative Review. Int J Alzheimers Dis. 2016;2016:5131570. doi: 10.1155/2016/5131570. Epub 2016 Jul 11.
PubMed 27478677Desai R, Leung WG, Fearn C, John A, Stott J, Spector A. Effectiveness of Cognitive Stimulation Therapy (CST) for mild to moderate dementia: A systematic literature review and meta-analysis of randomised control trials using the original CST protocol. Ageing Res Rev. 2024 Jun;97:102312. doi: 10.1016/j.arr.2024.102312. Epub 2024 Apr 16.
PubMed 38636561
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrainLive Connect: Non-professional Delivered Cognitive Stimulation Therapy for People Living With Dementia
- ClinicalTrials.gov ID
- NCT07531589
- Acronym / sponsor ID
- EA250765a
- Conditions
- Dementia
- Keywords
- Dementia, Cognitive Stimulation Therapy, Volunteer-led intervention, Quality of life, Cognitive function, BrainLive Connect, Care burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Simon K.Y.Lee Foundation, Yang Memorial Methodist Social Service, Christian Family Service Centre, Hong Kong Young Women's Christian Association
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 15 Apr 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.
The goal of this mixed method study is to evaluate whether the volunteer-led Cognitive Stimulation Therapy (CST) under the BrainLive Connect programme is effective for improving cognitive function and quality of life of people living with dementia (PLwD).
The main question it aims to answer are:
- Do PLwD receiving the BrainLive Connect service show better cognitive function and quality of life than those receiving usual care?
Researchers will compare BrainLive Connect service to usual care to see whether the intervention leads to better outcomes.
Participants will:
- Receive either 7 weeks of BrainLive Connect sessions delivered by trained volunteers or continue receiving usual care.
- Be assessed at baseline (T0), post-intervention (7 weeks; T1), and 1 month follow up (11 weeks; T2).
- Take part in semi-strucutred interviews post-intervention to provide feedback on implementation and areas for improvement.
Detailed description
The research design is a non-randomized controlled trial (nRCT), involving 260 PLwD in the experimental group (BrainLive group) who will receive 7 weeks of BrainLive Connect service, and another 260 PLwD in the control group (Care-as-usual group) who will receive usual care for comparison. Participants of the experimental group will be recruited by our partnering NGOs, and those of the control group will be from both the partnering NGOs and network of HKU. Outcomes of PLwD and their carers will be measured at three time points: intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2), to assess the lasting effects of the volunteer-led CST. During the evaluation period, participants in the control group will receive standard care and support.
The BrainLive Connect service aimed at maintaining cognitive functions, and improving quality of life (Primary outcomes); and reducing distressed behaviour, improving social functioning, reduced carer burden, improving daily functioning, and preference for ageing-in-place (Secondary outcomes).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-professional delivered CST | Experimental | Behavioral: Cognitive Stimulation Therapy (CST)Participants will receive 14-session Cognitive Stimulation Therapy (CST) delivered by trained volunteers, with two sessions per week over a period of 7 weeks |
| Usual social care | Active comparator | Other: Usual CareParticipants will receive usual social care and support provided by elderly care service units operated by non-governmental organisations, including but not limited to care services, psychosocial intervention, and social activites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PLwD: Hong Kong residents, mild to moderate dementia, either having i) a formal diagnosis, or 2) suspected dementia reported by care professionals and screened by Montreal Cognitive Assessment (MoCA).
- Family carers: self-identified as the primary carer of the PLwD.
Key exclusion criteria (1 listed)
- Unable to communicate and participate in interviews/training/intervention due to hearing impairment, visual impairment, or other conditions.
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 |
|---|---|---|
| Cognitive Stimulation Therapy (CST)CST has been recognized as an effective and cost-effective intervention for individuals with mild to moderate dementia, leading to improvements in cognition and quality of life. CST is one of the few non-pharmacological interventions recommended by the National Institute for Health and Care Excellence (NICE) in their clinical guideline on dementia, as it has comparable efficacy to anti-dementia drugs. Exercise-enhanced CST is characterised by adding physical exercise into the original group CST protocol. Home2Community CST is characterized by a gradual shift of its intervention site from the participant's home to public space in their neighbourhood and then further to centre-based settings. Living CST is characterised by transferring CST into real life settings to maximise its benefits in daily functioning for independent living. | Behavioural | Non-professional delivered CST |
| Usual CareUsual care and support service for people living with dementia in community, including but not limited to, care service, psychosocial intervention (but not CST), and social activities. | Other | Usual social care |
Primary outcome
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Possible range: 0 -70, with higher scores indicate more impairment
Quality of Life-Alzheimer's Disease (QoL-AD)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Possible range: 13 - 52, with higher scores indicate better quality of life
7 secondary outcomes
Neuropsychiatric Inventory Questionnaire (NPIQ)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Social functioning in Dementia Scale (HKSF-DEM: carer rating)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Care burden (Zarit Burden Interview short version, 12-item)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
The Lawton Instrumental Activities of Daily Living (IADL)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Preference for ageing-in place (self-developed scale)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
Preparation of ageing in-place (self-developed scale)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
The Montreal Cognitive Assessment subscale (MoCA subscale)
Time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)
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 21 Apr 2026.
- Background: PubMed 26607411Groot C, Hooghiemstra AM, Raijmakers PG, van Berckel BN, Scheltens P, Scherder EJ, van der Flier WM, Ossenkoppele R. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials. Ageing Res Rev. 2016 Jan;25:13-23. doi: 10.1016/j.arr.2015.11.005. Epub 2015 Nov 28.
- Background: PubMed 34613622Knapp M, Bauer A, Wittenberg R, Comas-Herrera A, Cyhlarova E, Hu B, Jagger C, Kingston A, Patel A, Spector A, Wessel A, Wong G. What are the current and projected future cost and health-related quality of life implications of scaling up cognitive stimulation therapy? Int J Geriatr Psychiatry. 2022 Jan;37(1). doi: 10.1002/gps.5633. Epub 2021 Oct 15.
- Background: PubMed 16738349Knapp M, Thorgrimsen L, Patel A, Spector A, Hallam A, Woods B, Orrell M. Cognitive stimulation therapy for people with dementia: cost-effectiveness analysis. Br J Psychiatry. 2006 Jun;188:574-80. doi: 10.1192/bjp.bp.105.010561.
- Background: PubMed 30011160Dementia: Assessment, management and support for people living with dementia and their carers. London: National Institute for Health and Care Excellence (NICE); 2018 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK513207/
- Background: PubMed 40337614Ryan S, Brady O. Cognitive stimulation and activities of daily living for individuals with mild-to-moderate dementia: A scoping review. Br J Occup Ther. 2023 Aug;86(8):540-559. doi: 10.1177/03080226231156517. Epub 2023 Mar 15.
- Background: PubMed 27478677Toh HM, Ghazali SE, Subramaniam P. The Acceptability and Usefulness of Cognitive Stimulation Therapy for Older Adults with Dementia: A Narrative Review. Int J Alzheimers Dis. 2016;2016:5131570. doi: 10.1155/2016/5131570. Epub 2016 Jul 11.
- Background: PubMed 38636561Desai R, Leung WG, Fearn C, John A, Stott J, Spector A. Effectiveness of Cognitive Stimulation Therapy (CST) for mild to moderate dementia: A systematic literature review and meta-analysis of randomised control trials using the original CST protocol. Ageing Res Rev. 2024 Jun;97:102312. doi: 10.1016/j.arr.2024.102312. Epub 2024 Apr 16.
- Individual participant dataSharing planned: Yes. Anonymised data will be available upon request.
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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.
Shiyu LU principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulation Therapy (CST) in people with Dementia, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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 21 Apr 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 Hong Kong. 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 JACKY CP CHOY, PhD (+852 39170079, cpchoy@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) (time frame: Intake (T0), a 7-week follow-up (T1), and a one-month follow-up (T2)). The study lists 2 primary outcomes in all. 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 NCT07531589, which also lists 7 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 21 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.