Cognitive DeclineADL+ 2NCT07141160
ADL+2.0: Intervention for Prevention of Cognitive Decline in Community-dwelling Older Adults
A study testing Combined: Mobile app + 6WELLS and Remote mobile based app in people with Cognitive Decline, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Singapore's rising dementia incidence with an ageing population presents an urgent need for effective interventions that delay or prevent cognitive decline. While multi-domain intervention studies for dementia prevention show promise, there is a need for an effective personalised approach to address an individual's… Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Combined: Mobile app + 6WELLS and Remote mobile based app
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteSingapore
- Study dates
- 8 May 2025to 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 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥60 Years old
- Participants from partnering Active Ageing Centres (AACs) across Singapore
- Subjective memory complaint (AD8 ≥ 2)
- Independent in activities of daily living (ADL)
- Able to speak English and/or Mandarin
- Comfortable with using smartphones
- Not currently enrolled in a formal cognitive training program.
Who cannot join
- Known dementia or suspected dementia after initial screening
- Significant medical illnesses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ADL+2.0: Intervention for Prevention of Cognitive Decline in Community-dwelling Older Adults.
Singapore's rising dementia incidence with an ageing population presents an urgent need for effective interventions that delay or prevent cognitive decline. While multi-domain intervention studies for dementia prevention show promise, there is a need for an effective personalised approach to address an individual's multifactorial risks for dementia, and to achieve cost-effective, scalable and sustainable outcomes for wider implementation.
The investigators propose the ADL+ 2.0 programme, an overall goal is to delay or prevent cognitive decline in at-risk individuals without dementia aged 60 and above with subjective memory complaints and/or impaired cognitive capacity from the ICOPE screening tool. Through a population-level, technology-enabled, community-based preventative approach, ADL+ 2.0 provides remote assessment and multi-component intervention (cognitive training, dual-task exercises, and cognitive wellness) with smart scheduling and personalized intervention, and can be delivered in conjunction with the onsite 6 WELLS facilitated group-based activity, underpinned by the Self-Determination Theory to foster intrinsic motivation for lasting behavioural change.
Read more
The approach begins with phase 1 test-bedding approach Type 1 hybrid effectiveness-implementation study to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme. The investigators will conduct a 3-arm cluster-randomised controlled trial comparing remote/onsite, remote only, and control groups to assess the impact on cognitive outcomes, social networks, quality-of-life and cost-effectiveness. Barriers and facilitators will be identified for implementation, guided by the Consolidated Framework for Implementation Research.
Together with NTU-LILY/LKCMedicine as technology partner and community partners (NTUC Health, Fei Yue Community Services, and evaluation partners (GERI/NUS) to provide evidence for and effectively implement a scalable, sustainable, and cost-effective community programme for the prevention of cognitive decline in Singapore.
Read the detailed description
An estimated one in 10 people aged 60 and above in Singapore suffers from dementia. With increasing life expectancy and a rapidly ageing population, the number of persons living with dementia is expected to continue to rise, with significant negative consequences at individual, societal and healthcare system levels. To address this problem, multidomain non-pharmacological interventions aimed at addressing various risk factors for dementia prevention hold promise. However, a gap exists in overcoming practical barriers, demonstrating cost-effectiveness, and ensuring scalability and sustainability of these interventions.
To address these gaps, the investigators propose ADL+ 2.0: Intervention for prevention of cognitive decline in community-dwelling older adults. The ADL+ 2.0 programme takes a population-level, technology-enabled, community- based preventative approach, targeting community-dwelling individuals without dementia aged 60 years and above who are at risk of cognitive decline. Type 1 hybrid effectiveness-implementation study will be conducted to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme.
Firstly, to determining the effectiveness of the ADL+ 2.0 programme in improving cognition, social participation, and health-related quality of life amongst older persons at risk of cognitive decline serves as a pre- requisite before further implementation and scaling in the community. Secondly, determining the cost-effectiveness of the ADL+ 2.0 programme is important to understand the funding and resource implications for longer-term sustainability. Lastly, explicating the facilitators and barriers for participation/adherence at the individual user level and delivery of programme at the systems level will enable the study team to develop implementation strategies and further refine and develop the ADL+ 2.0 intervention in the scale up (deployment) phase.
- Conditions
- Cognitive Decline
- Being tested
- Combined: Mobile app + 6WELLS, Remote mobile based app
- Keywords
- Subjective memory complaints, Technology-enabled, Multi-component intervention, Cognitive decline, Intrinsic motivation, Prevention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined: Mobile app + 6WELLSOther
Mobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. Together with onsite 6 WELLS Group-Based Activity is a structured, group-based, cognitive health promotion programme that aims to build communities of practice, stimulate goal attainment, and drive behavioural change towards cognitive health and wellbeing. The curriculum is delivered via a 10-week onsite programme comprising weekly facilitated small-group activities centred on six key components.
Remote mobile based appOther
Mobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training.
| Study group | Role | What they receive |
|---|---|---|
| Remote mobile based app | Experimental | Mobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. Receives: Other: Combined: Mobile app + 6WELLS |
| Combined: Mobile app + 6WELLS | Experimental | Mobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. Together with onsite 6 WELLS Group-Based Activity is a structured, group-based, cognitive health promotion programme that aims to build communities of practice, stimulate goal attainment, and drive behavioural change towards cognitive health and wellbeing. The curriculum is delivered via a 10-week onsite programme comprising weekly facilitated small-group activities centred on six key components. Receives: Other: Remote mobile based app |
| Educational booklet and health talk | Sham comparator | Education booklet and a health talk on cognition. The booklet and health talk will be provided to the participants, it comprises of tips for maintaining cognitive health. Both aims to promote the awareness for normal ageing and dementia. Receives: Other: Combined: Mobile app + 6WELLS; Other: Remote mobile based app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive test performance
The primary efficacy outcome will be change in cognitive test performance in composite and individual domain z- scores using a standardised neuropsychological test battery (NTB) comprising the 5 domains of attention, processing speed, memory, language, and executive function.
Measured: Through study completion, an average of 9 months
Secondary outcomes (3)
Efficacy outcomes - Cognition
The investigators will assess subjective memory complaints using the locally validated AD8 questionnaire. Possible scores range from 0-1 (normal cognition) to 2-8 (cognitive impairment is likely to be present).
Measured: through study completion, an average of 9 month
Efficacy outcomes - Function & Social
Investigators will look at the transfer of cognitive benefits to activities of daily living using the Alzheimer's Disease Cooperative Study- Activities of Daily Living Prevention Instrument (ADCS-PI). The ADCS-PI consists of 15 IADL tasks and 5 physical function questions. Lubben Social Network Scale (LSNS-6) will be used to assesses the domains of social isolation and Frenchay Acitivities Index to assess participation in social activities.
Measured: through study completion, an average of 9 month
Efficacy outcomes - Quality of Life
Health-related quality of life (QOL) will be assess using the 5-level EuroQol 5-dimension (EQ-5D-5L) to derive utility scores based on Singapore preference weights derived using an indirect interim mapping method, and to estimate quality adjusted life years (QALY). 11-item Control, Autonomy, Self-realisation, and Pleasure (CASP-11) tool, which was developed specifically to assess emotional QOL in older adults. CASP-11 has a total score range of 0 to 33. A higher score indicates a higher quality of life.
Measured: through study completion, an average of 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start8 May 2025
- Primary completion30 Aug 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- This is a type 1 hybrid effectiveness-implementation to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme. The effectiveness study will use a cluster randomised trial design that compares 3 participant groups: a) receiving a combination of remote and onsite interventions, b) receiving only remote interventions, and c) education booklet + health talk group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University, Geriatric Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- Wee Shiong Lim, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141160
- Sponsor's protocol ID
- ECOS Ref 2024-4524
- Acronym
- ADL+ 2
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADL+2.0: Intervention for Prevention of Cognitive Decline in Community-dwelling Older Adults.
- ClinicalTrials.gov ID
- NCT07141160
- Acronym / sponsor ID
- ADL+ 2 / ECOS Ref 2024-4524
- Conditions
- Cognitive Decline
- Keywords
- Subjective memory complaints, Technology-enabled, Multi-component intervention, Cognitive decline, Intrinsic motivation, Prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Nanyang Technological University, Geriatric Education and Research Institute
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Aug 2025 (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.
Singapore's rising dementia incidence with an ageing population presents an urgent need for effective interventions that delay or prevent cognitive decline. While multi-domain intervention studies for dementia prevention show promise, there is a need for an effective personalised approach to address an individual's multifactorial risks for dementia, and to achieve cost-effective, scalable and sustainable outcomes for wider implementation.
The investigators propose the ADL+ 2.0 programme, an overall goal is to delay or prevent cognitive decline in at-risk individuals without dementia aged 60 and above with subjective memory complaints and/or impaired cognitive capacity from the ICOPE screening tool. Through a population-level, technology-enabled, community-based preventative approach, ADL+ 2.0 provides remote assessment and multi-component intervention (cognitive training, dual-task exercises, and cognitive wellness) with smart scheduling and personalized intervention, and can be delivered in conjunction with the onsite 6 WELLS facilitated group-based activity, underpinned by the Self-Determination Theory to foster intrinsic motivation for lasting behavioural change.
The approach begins with phase 1 test-bedding approach Type 1 hybrid effectiveness-implementation study to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme. The investigators will conduct a 3-arm cluster-randomised controlled trial comparing remote/onsite, remote only, and control groups to assess the impact on cognitive outcomes, social networks, quality-of-life and cost-effectiveness. Barriers and facilitators will be identified for implementation, guided by the Consolidated Framework for Implementation Research.
Together with NTU-LILY/LKCMedicine as technology partner and community partners (NTUC Health, Fei Yue Community Services, and evaluation partners (GERI/NUS) to provide evidence for and effectively implement a scalable, sustainable, and cost-effective community programme for the prevention of cognitive decline in Singapore.
Detailed description
An estimated one in 10 people aged 60 and above in Singapore suffers from dementia. With increasing life expectancy and a rapidly ageing population, the number of persons living with dementia is expected to continue to rise, with significant negative consequences at individual, societal and healthcare system levels. To address this problem, multidomain non-pharmacological interventions aimed at addressing various risk factors for dementia prevention hold promise. However, a gap exists in overcoming practical barriers, demonstrating cost-effectiveness, and ensuring scalability and sustainability of these interventions.
To address these gaps, the investigators propose ADL+ 2.0: Intervention for prevention of cognitive decline in community-dwelling older adults. The ADL+ 2.0 programme takes a population-level, technology-enabled, community- based preventative approach, targeting community-dwelling individuals without dementia aged 60 years and above who are at risk of cognitive decline. Type 1 hybrid effectiveness-implementation study will be conducted to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme.
Firstly, to determining the effectiveness of the ADL+ 2.0 programme in improving cognition, social participation, and health-related quality of life amongst older persons at risk of cognitive decline serves as a pre- requisite before further implementation and scaling in the community. Secondly, determining the cost-effectiveness of the ADL+ 2.0 programme is important to understand the funding and resource implications for longer-term sustainability. Lastly, explicating the facilitators and barriers for participation/adherence at the individual user level and delivery of programme at the systems level will enable the study team to develop implementation strategies and further refine and develop the ADL+ 2.0 intervention in the scale up (deployment) phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a type 1 hybrid effectiveness-implementation to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme. The effectiveness study will use a cluster randomised trial design that compares 3 participant groups: a) receiving a combination of remote and onsite interventions, b) receiving only remote interventions, and c) education booklet + health talk group.
| Arm | Type | Receives |
|---|---|---|
| Remote mobile based app | Experimental | Other: Combined: Mobile app + 6WELLSMobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. |
| Combined: Mobile app + 6WELLS | Experimental | Other: Remote mobile based appMobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. Together with onsite 6 WELLS Group-Based Activity is a structured, group-based, cognitive health promotion programme that aims to build communities of practice, stimulate goal attainment, and drive behavioural change towards cognitive health and wellbeing. The curriculum is delivered via a 10-week onsite programme comprising weekly facilitated small-group activities centred on six key components. |
| Educational booklet and health talk | Sham comparator | Other: Combined: Mobile app + 6WELLS, Other: Remote mobile based appEducation booklet and a health talk on cognition. The booklet and health talk will be provided to the participants, it comprises of tips for maintaining cognitive health. Both aims to promote the awareness for normal ageing and dementia. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥60 Years old
- Participants from partnering Active Ageing Centres (AACs) across Singapore
- Subjective memory complaint (AD8 ≥ 2)
- Independent in activities of daily living (ADL)
- Able to speak English and/or Mandarin
Key exclusion criteria (2 listed)
- Known dementia or suspected dementia after initial screening
- Significant medical illnesses
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 |
|---|---|---|
| Combined: Mobile app + 6WELLSMobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. Together with onsite 6 WELLS Group-Based Activity is a structured, group-based, cognitive health promotion programme that aims to build communities of practice, stimulate goal attainment, and drive behavioural change towards cognitive health and wellbeing. The curriculum is delivered via a 10-week onsite programme comprising weekly facilitated small-group activities centred on six key components. | Other | Educational booklet and health talk, Remote mobile based app |
| Remote mobile based appMobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. | Other | Combined: Mobile app + 6WELLS, Educational booklet and health talk |
Primary outcome
Cognitive test performance
Time frame: Through study completion, an average of 9 months
The primary efficacy outcome will be change in cognitive test performance in composite and individual domain z- scores using a standardised neuropsychological test battery (NTB) comprising the 5 domains of attention, processing speed, memory, language, and executive function.
3 secondary outcomes
Efficacy outcomes - Cognition
Time frame: through study completion, an average of 9 month
Efficacy outcomes - Function & Social
Time frame: through study completion, an average of 9 month
Efficacy outcomes - Quality of Life
Time frame: through study completion, an average of 9 month
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Wee Shiong Lim principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined: Mobile app + 6WELLS and Remote mobile based app in people with Cognitive Decline, run by Tan Tock Seng 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 7 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive test performance (time frame: Through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.