Age-related Cognitive DeclineNCT05728801
Decoding the Cognitive Trajectory of Hong Kong SuperAgers: a Longitudinal Follow-up Study
An observational study of Age-related Cognitive Decline and Cognitive Deterioration, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective follow-up study conducted at the Department of Psychiatry, The Chinese University of Hong Kong. The participants, including high-performing elderly (SuperAgers), normal ageing elderly and neurocognitive disorder (NCD) patients will be re-invited from our previous cohort (2013-2014) (N=488). Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline, Cognitive Deterioration, Dementia, Mild
- What is being tested?
- Ageing
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: High-performing elderly (SuperAgers) and the cases with normal ageing and neurocognitive disorder (NCD) will be re-invited in this study.
Who may be able to join
- SuperAgers are determined by the scores of global cognitive function. This ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest;
- Normal aging: the cases with the scores of cognitive performance within 1.5 standard deviation (SD) of age and education matched normative values derived from our cohort study, of which presented with HK MoCA score greater than 26 and CDR score equal to 0;
- NCD patients are defined as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 SD below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders.
Who cannot join
- History of bipolar disorders or psychosis;
- History of major neurological deficits including stroke, transient ischemic attack or traumatic brain injury;
- Comorbidities with depressive symptoms.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Tai Po Hospital
Hong Kong
Candy Wong, 85226076063, candy.wong@cuhk.edu.hk
About this study
This is a prospective follow-up study conducted at the Department of Psychiatry, The Chinese University of Hong Kong. The participants, including high-performing elderly (SuperAgers), normal ageing elderly and neurocognitive disorder (NCD) patients will be re-invited from our previous cohort (2013-2014) (N=488).
Read the detailed description
Objectives: This study aims to investigate the cognitive changes in older adults with different cognitive statuses.
- Being tested
- Ageing
- Keywords
- Cognitive maintenance, Cognitive ageing, Superagers, Cognition, Quality of life, Brain health
- Medical subject headings
- Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgeingDiagnostic test
Using comprehensive cognitive tests to quality the domain-specific cognitive changes during ageing.
| Study group | Role | What they receive |
|---|---|---|
| Superagers | SuperAgers are determined by the scores of global cognitive function. This ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest. Receives: Diagnostic Test: Ageing | |
| Normal ageing elderly | The cases with the scores of cognitive performance within 1.5 standard deviation (SD) of age and education matched normative values derived from our cohort study, of which presented with HK MoCA score greater than 26 and CDR score equal to 0 Receives: Diagnostic Test: Ageing | |
| Neurocognitive disorders patients | NCD patients are defined as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 SD below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders. Receives: Diagnostic Test: Ageing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA)
The Montreal Cognitive Assessment Hong Kong version (HK MoCA) is a validated and widely used screening assessment for detecting cognitive impairment, which measures an array of cognitive functions such as visuospatial, memory, language and attention.HK MoCA score less than 26 indicates cognitive impairments.
Measured: 2022-2024
Complex attention will be measured by Attention Network Test (ANT)
Attention Network Test (ANT). The ANT paradigm (Download from: https://www.sacklerinstitute.org/cornell/assays_and_tools/ant/jin.fan/), as a computerized test, was used and performed by E-Prime 3.0 (Psychology Software Tools, PA, USA). Within ANT paradigm, there are four types of cue: no cue, center cue, double cue, and spatial cue; and three types of flanker: neutral, congruent, and incongruent. In a given trial, a central cross-fixation point presents for 400 to 1,600 ms (randomized), subsequently is replaced for 100 ms by one of four warning cues. The target, a central arrow could appear above or below the cross-fixation and is surrounded by two flankers on each side.
Measured: 2022-2024
Secondary outcomes (1)
Learning and memory will be measured by Word list learning test (WLLT)
Word list learning test (WLLT) consisting of fifteen semantically non-associated words that is presented consecutively over three free trials of immediate recall (i.e., learning ability), a 20-min delayed recall (to prevent recency effects) and followed by yes/no recognition (i.e., recognition memory). Based on the proxies we developed in our previous work, components of learning and memory function will be evaluated and compared across groups, including working memory capacity (WMC), forgetting rate, delayed recall, initial learning, best learning, learning over trials (LOT) and learning ratio.
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LU Hanna, Chinese University of Hong Kong
- Investigators
- Hanna LU, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728801
- Sponsor's protocol ID
- 2019.078
- Status last verified
- Dec 2023
- First submitted
- 6 Feb 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding the Cognitive Trajectory of Hong Kong SuperAgers: a Longitudinal Follow-up Study
- ClinicalTrials.gov ID
- NCT05728801
- Acronym / sponsor ID
- 2019.078
- Keywords
- Cognitive maintenance, Cognitive ageing, Superagers, Cognition, Quality of life, Brain health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Feb 2023 (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 is a prospective follow-up study conducted at the Department of Psychiatry, The Chinese University of Hong Kong. The participants, including high-performing elderly (SuperAgers), normal ageing elderly and neurocognitive disorder (NCD) patients will be re-invited from our previous cohort (2013-2014) (N=488).
Detailed description
Objectives: This study aims to investigate the cognitive changes in older adults with different cognitive statuses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Superagers | – | Diagnostic Test: AgeingSuperAgers are determined by the scores of global cognitive function. This ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest. |
| Normal ageing elderly | – | Diagnostic Test: AgeingThe cases with the scores of cognitive performance within 1.5 standard deviation (SD) of age and education matched normative values derived from our cohort study, of which presented with HK MoCA score greater than 26 and CDR score equal to 0 |
| Neurocognitive disorders patients | – | Diagnostic Test: AgeingNCD patients are defined as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 SD below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- High-performing elderly (SuperAgers) and the cases with normal ageing and neurocognitive disorder (NCD) will be re-invited in this study.
Key inclusion criteria (3 listed)
- SuperAgers are determined by the scores of global cognitive function. This ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest;
- Normal aging: the cases with the scores of cognitive performance within 1.5 standard deviation (SD) of age and education matched normative values derived from our cohort study, of which presented with HK MoCA score greater than 26 and CDR score equal to 0;
- NCD patients are defined as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 SD below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders.
Key exclusion criteria (3 listed)
- History of bipolar disorders or psychosis;
- History of major neurological deficits including stroke, transient ischemic attack or traumatic brain injury;
- Comorbidities with depressive symptoms.
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 |
|---|---|---|
| AgeingUsing comprehensive cognitive tests to quality the domain-specific cognitive changes during ageing. | Diagnostic test | Neurocognitive disorders patients, Normal ageing elderly, Superagers |
Primary outcome
Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA)
Time frame: 2022-2024
The Montreal Cognitive Assessment Hong Kong version (HK MoCA) is a validated and widely used screening assessment for detecting cognitive impairment, which measures an array of cognitive functions such as visuospatial, memory, language and attention.HK MoCA score less than 26 indicates cognitive impairments.
Complex attention will be measured by Attention Network Test (ANT)
Time frame: 2022-2024
Attention Network Test (ANT). The ANT paradigm (Download from: https://www.sacklerinstitute.org/cornell/assays_and_tools/ant/jin.fan/), as a computerized test, was used and performed by E-Prime 3.0 (Psychology Software Tools, PA, USA). Within ANT paradigm, there are four types of cue: no cue, center cue, double cue, and spatial cue; and three types of flanker: neutral, congruent, and incongruent. In a given trial, a central cross-fixation point presents for 400 to 1,600 ms (randomized), subsequently is replaced for 100 ms by one of four warning cues. The target, a central arrow could appear above or below the cross-fixation and is surrounded by two flankers on each side.
1 secondary outcome
Learning and memory will be measured by Word list learning test (WLLT)
Time frame: 2022-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Hong Kong SuperAgersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hanna LU, PhD principal investigator
Chinese 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?
An observational study of Age-related Cognitive Decline and Cognitive Deterioration, run by Chinese 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 3 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna LU, PhD (85226076063, hannalu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA) (time frame: 2022-2024). 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?
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 12 Dec 2023.