Cognitive ImpairmentCOGENTNCT07829380
The Cardiovascular-Cognitive Health Initiative
A study testing Structured cognitive and cardiovascular interventions in people with Cognitive Impairment, run by National Heart Centre Singapore at 4 sites in Singapore.
Trial summary
This study aims to understand how memory and thinking abilities (cognition) are affected in patients with heart conditions, and to find out if early detection and interventions can improve health outcomes. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Structured cognitive and cardiovascular interventions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 4 sitesSingapore
- Study dates
- 4 Aug 2026to Dec 2030
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main Study:
- Age ≥ 21 years.
- Able and willing (or via legally acceptable representative, LAR, where appropriate) to provide informed consent.
- RCT Sub-Study (Mild cognitive impairment (MCI) arm):
- Meets main study criteria.
- Mild cognitive impairment defined by: (i) Montreal cognitive assessment (MoCA) <26 but ≥21; and/or (ii) impairment in at least one domain on standardized neuropsychological testing and/or (iii) MMSE <28 but ≥24.
Who cannot join
- Neurodegenerative disorders or major psychiatric illnesses that substantially impair cognition.
- Terminal illness or advanced major organ disease limiting participation with expected survival of less than 1 year.
- Severe depression, anxiety, or stress where participation may be inappropriate.
- Any condition which, in the investigator's opinion, would compromise safety or study integrity.
- Note: Pregnant and breast-feeding women may not take part in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore4 sites, 4 recruiting
- Not yet recruiting
Alexandra Hospital
Singapore
Laureen Yi Ting Wang, MBBS, +6569082222, laureen_yt_wang@nuhs.edu.sg
Cheryl Tan, Cheryl_TAN_PT@nuhs.edu.sg
- Not yet recruiting
Khoo Teck Puat Hospital
Singapore
Siew Fei Yap, MBBS, +6565558000, yap.siew.fei@nhghealth.com.sg
- Recruiting
National Heart Centre Singapore
Singapore
Angela S. Koh, MBBS, +6567048961, angela.koh.s.m@singhealth.com.sg
Mee Yin Wong, BSc, +6567042302, wong.mee.yin@nhcs.com.sg
- Not yet recruiting
Sengkang General Hospital
Singapore
Chiw Yeh Lim, MBBS, +6569302566, lim.chiw.yeh@singhealth.com.sg
Margaret Sok Teng Tan, +6567042261, margaret.tan.s.t@singhealth.com.sg
About this study
This study aims to understand how memory and thinking abilities (cognition) are affected in patients with heart conditions, and to find out if early detection and interventions can improve health outcomes.
Read the detailed description
Cardiovascular disease (CVD) and cognitive impairment frequently coexist in aging populations and accelerate each other's deterioration through shared vascular and neurobiological pathways.
Primary objectives:
- To determine the prevalence and profile of cognitive impairment in patients with cardiovascular disease ii. For the RCT, to compare the proportion of patients who demonstrate improvement in cognitive test scores by 24 weeks between intervention and usual care arms.
Secondary objectives:
- To evaluate changes in neuropsychological domains (e.g. memory, processing speed), mental health, frailty, and quality of life over time. ii. To study the association between cognitive status and cardiovascular treatment plan categories.
- Conditions
- Cognitive Impairment
- Being tested
- Structured cognitive and cardiovascular interventions
- Keywords
- cognitive assessment, cardiovascular disease
- Medical subject headings
- Cognitive Dysfunction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured cognitive and cardiovascular interventionsOther
The intervention arm (RCT R1 cohort) will receive a 24-week multi-component program combining cardiac rehabilitation instruction, cognitive stimulation via a hybrid hospital and home-based telehealth platform.
| Study group | Role | What they receive |
|---|---|---|
| Main (Observational) Cohort | No intervention | Required procedures during baseline visit: i. Blood pressure test ii. Biospecimen collection (Optional) iii. Musculoskeletal analysis iv. Memory test: MoCA and MMSE |
| Randomized Controlled Trial (RCT) R1 Cohort | Other | Baseline:
1. Cardiovascular measurements:-
* Blood pressure test
* Echocardiography
* Electrocardiography
2. Biospecimen collection
3. Six-minute walk test
4. Musculoskeletal Analysis
5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX)
6. Magnetic resonance imaging
7. Neuropsychological assessment
During Intervention:
12 exercise sessions and 12 cognitive sessions
Post-Intervention:
1. Same procedures as Baseline except CPET / TMX
2. Post-intervention questionnaire
3. Qualitative interview (Optional) Receives: Other: Structured cognitive and cardiovascular interventions |
| Randomized Controlled Trial (RCT) R2 Cohort | No intervention | Baseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment Post-Intervention: 1. Same procedures as Baseline, except CPET / TMX 2. Post-intervention questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary RCT Outcome
Proportion of participants demonstrating clinically meaningful improvement in cognitive function at 24 weeks, defined as a pre-specified increase in standardized cognitive test scores.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start4 Aug 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are both cohorts: main (observational) and randomized controlled trial (RCT) cohort. Participants in the RCT cohort will be randomized to receive exercise and cognitive intervention (Group R1) or no exercise nor cognitive intervention (Group R2).
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829380
- Sponsor's protocol ID
- 2025/1892
- Other IDs
- NICCOG2024-0024
- Acronym
- COGENT
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular-Cognitive Health Initiative
- ClinicalTrials.gov ID
- NCT07829380
- Acronym / sponsor ID
- COGENT / 2025/1892
- Conditions
- Cognitive Impairment
- Keywords
- cognitive assessment, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Sep 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 aims to understand how memory and thinking abilities (cognition) are affected in patients with heart conditions, and to find out if early detection and interventions can improve health outcomes.
Detailed description
Cardiovascular disease (CVD) and cognitive impairment frequently coexist in aging populations and accelerate each other's deterioration through shared vascular and neurobiological pathways.
Primary objectives:
- To determine the prevalence and profile of cognitive impairment in patients with cardiovascular disease ii. For the RCT, to compare the proportion of patients who demonstrate improvement in cognitive test scores by 24 weeks between intervention and usual care arms.
Secondary objectives:
- To evaluate changes in neuropsychological domains (e.g. memory, processing speed), mental health, frailty, and quality of life over time. ii. To study the association between cognitive status and cardiovascular treatment plan categories.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are both cohorts: main (observational) and randomized controlled trial (RCT) cohort. Participants in the RCT cohort will be randomized to receive exercise and cognitive intervention (Group R1) or no exercise nor cognitive intervention (Group R2).
| Arm | Type | Receives |
|---|---|---|
| Main (Observational) Cohort | No intervention | –Required procedures during baseline visit: i. Blood pressure test ii. Biospecimen collection (Optional) iii. Musculoskeletal analysis iv. Memory test: MoCA and MMSE |
| Randomized Controlled Trial (RCT) R1 Cohort | Other | Other: Structured cognitive and cardiovascular interventionsBaseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment During Intervention: 12 exercise sessions and 12 cognitive sessions Post-Intervention: 1. Same procedures as Baseline except CPET / TMX 2. Post-intervention questionnaire 3. Qualitative interview (Optional) |
| Randomized Controlled Trial (RCT) R2 Cohort | No intervention | –Baseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment Post-Intervention: 1. Same procedures as Baseline, except CPET / TMX 2. Post-intervention questionnaire |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 21 years.
- Able and willing (or via legally acceptable representative, LAR, where appropriate) to provide informed consent.
- Meets main study criteria.
- Mild cognitive impairment defined by: (i) Montreal cognitive assessment (MoCA) <26 but ≥21; and/or (ii) impairment in at least one domain on standardized neuropsychological testing and/or (iii) MMSE <28 but ≥24.
Key exclusion criteria (5 listed)
- Neurodegenerative disorders or major psychiatric illnesses that substantially impair cognition.
- Terminal illness or advanced major organ disease limiting participation with expected survival of less than 1 year.
- Severe depression, anxiety, or stress where participation may be inappropriate.
- Any condition which, in the investigator's opinion, would compromise safety or study integrity.
- Note: Pregnant and breast-feeding women may not take part in this study.
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 |
|---|---|---|
| Structured cognitive and cardiovascular interventionsThe intervention arm (RCT R1 cohort) will receive a 24-week multi-component program combining cardiac rehabilitation instruction, cognitive stimulation via a hybrid hospital and home-based telehealth platform. | Other | Randomized Controlled Trial (RCT) R1 Cohort |
Primary outcome
Primary RCT Outcome
Time frame: 24 weeks
Proportion of participants demonstrating clinically meaningful improvement in cognitive function at 24 weeks, defined as a pre-specified increase in standardized cognitive test scores.
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 Sep 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured cognitive and cardiovascular interventions in people with Cognitive Impairment, run by National Heart Centre Singapore at 4 sites 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 6 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 21 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 4 sites 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 Angela S. Koh, MBBS (+6567048961, angela.koh.s.m@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary RCT Outcome (time frame: 24 weeks). 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 21 Sep 2026.