Cognition Disorders in Old AgeNCT06239922
Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults.
An observational study of Cognition Disorders in Old Age and Cognitive Decline, run by University of Macau at 1 site in Macau.
Trial summary
The current project is dedicated to creating a comprehensive cognitive and neural assessment platform and corresponding norms tailored specifically to the older adults in Macau. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders in Old Age, Cognitive Decline, Cognitive Impairment
- How many people
- 300 participants
- Where
- 1 siteMacau
- Study dates
- Feb 2024to 30 Dec 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults above 50 years old from the Macau local community.
Who may be able to join
- Must be a local adult resident of Macau
- Age above 50 years for older adult cohort
- Younger adults individuals above 18 will be included as control comparators
Who cannot join
- History of neurological injury or disease
- Current use of medications that affect brain function or blood flow
- Contraindications to MRI scanning, such as the presence of an electric/mechanical implant or device (e.g., pacemaker)
- Claustrophobia
- Body weight over 300 lbs due to weight and physical constraints of the scanner (i.e., bore size limited to 55 cm)
- Inability to provide informed consent
Show all 9Show fewer
- Pregnancy
- Being under the legal age of adulthood (children)
- Incarcerated individuals (prisoners)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Macau1 site
Centre for Cognitive and Brain Sciences of the University of Macau
Macao, Macao SAR, 999078
Haoyun ZHANG Assistant Professor, +853 88229212, haoyunzhang@um.edu.mo
LEI KEI KEI Research Assistant, MSc, +853 8822 9198, keikeilei@umac.mo
About this study
Official title: Establishing Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults
The current project is dedicated to creating a comprehensive cognitive and neural assessment platform and corresponding norms tailored specifically to the older adults in Macau.
Read the detailed description
The investigators will establish this assessment platform using a combination of methods, including interviews, surveys, and expert reviews.
Steps include adapting existing assessment methods to the Macau context, developing new cognitive and neural tasks, defining standardized procedures, seeking external expert input, conducting pilot tests, and validation processes, and refining both the platform and its accompanying manual.
- Conditions
- Cognition Disorders in Old Age, Cognitive Decline, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Aging
- Keywords
- Macau, cognitive aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Older adults | |
| Group 2 | Younger adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative Data for the Montreal Cognitive Assessment - Chinese (Hong Kong) version
The MoCA will be administered to derive a normative data set representative of the older adult population in Macau.
Measured: From February 2024 to January 2026
Normative Data for the Mini-Mental State Examination (MMSE)
The MMSE will be administered to derive a normative data set representative of the older adult population in Macau.
Measured: From February 2024 to January 2026
Normative Scores for Computerized Neuropsychological Tasks
Neuropsychological tasks will be employed to measure selective attention capacity and processing speed in the study cohort. These tasks will provide quantifiable data on the efficiency and accuracy of cognitive processing. The collective performance on these tasks will be used to establish benchmark values - including means, medians, and ranges - that define the normative standards for these cognitive abilities in the population.
Measured: From February 2024 to January 2026
Secondary outcomes (3)
Neural Activation Patterns During Cognitive Tasks as Revealed by Functional Magnetic Resonance Imaging (fMRI)
fMRI data will be collected to identify patterns of neural activation associated with cognitive task performance.
Measured: From February 2024 to January 2026
Cerebral Hemodynamics Assessed Through Functional Near-Infrared Spectroscopy (fNIRS)
fNIRS will be employed to measure cerebral blood flow and oxygenation during cognitive tasks.
Measured: From February 2024 to January 2026
Electrophysiological Correlates of Cognitive Activity as Measured by Electroencephalography (EEG)
EEG will be utilized to record the electrical activity of the brain during cognitive tasks. Key outcome metrics will include event-related potentials (ERPs) amplitudes and latencies, with mean values and variability measures reported for the cohort.
Measured: From February 2024 to January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition Disorders in Old AgeStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Macau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haoyun ZHANG Assistant Professor, Ph.D, Principal investigator, University of Macau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239922
- Sponsor's protocol ID
- BSERE23-APP019-ICI
- Other IDs
- 0153/2022/A
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 2 Feb 2024
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults
- ClinicalTrials.gov ID
- NCT06239922
- Acronym / sponsor ID
- BSERE23-APP019-ICI
- Conditions
- Cognition Disorders in Old Age, Cognitive Decline, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Aging
- Keywords
- Macau, cognitive aging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Feb 2024 (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 current project is dedicated to creating a comprehensive cognitive and neural assessment platform and corresponding norms tailored specifically to the older adults in Macau.
Detailed description
The investigators will establish this assessment platform using a combination of methods, including interviews, surveys, and expert reviews.
Steps include adapting existing assessment methods to the Macau context, developing new cognitive and neural tasks, defining standardized procedures, seeking external expert input, conducting pilot tests, and validation processes, and refining both the platform and its accompanying manual.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Older adults |
| Group 2 | – | –Younger adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults above 50 years old from the Macau local community.
Key inclusion criteria (3 listed)
- Must be a local adult resident of Macau
- Age above 50 years for older adult cohort
- Younger adults individuals above 18 will be included as control comparators
Key exclusion criteria (9 listed)
- History of neurological injury or disease
- Current use of medications that affect brain function or blood flow
- Contraindications to MRI scanning, such as the presence of an electric/mechanical implant or device (e.g., pacemaker)
- Claustrophobia
- Body weight over 300 lbs due to weight and physical constraints of the scanner (i.e., bore size limited to 55 cm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normative Data for the Montreal Cognitive Assessment - Chinese (Hong Kong) version
Time frame: From February 2024 to January 2026
The MoCA will be administered to derive a normative data set representative of the older adult population in Macau.
Normative Data for the Mini-Mental State Examination (MMSE)
Time frame: From February 2024 to January 2026
The MMSE will be administered to derive a normative data set representative of the older adult population in Macau.
Normative Scores for Computerized Neuropsychological Tasks
Time frame: From February 2024 to January 2026
Neuropsychological tasks will be employed to measure selective attention capacity and processing speed in the study cohort. These tasks will provide quantifiable data on the efficiency and accuracy of cognitive processing. The collective performance on these tasks will be used to establish benchmark values - including means, medians, and ranges - that define the normative standards for these cognitive abilities in the population.
3 secondary outcomes
Neural Activation Patterns During Cognitive Tasks as Revealed by Functional Magnetic Resonance Imaging (fMRI)
Time frame: From February 2024 to January 2026
Cerebral Hemodynamics Assessed Through Functional Near-Infrared Spectroscopy (fNIRS)
Time frame: From February 2024 to January 2026
Electrophysiological Correlates of Cognitive Activity as Measured by Electroencephalography (EEG)
Time frame: From February 2024 to January 2026
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 2 Feb 2024.
- 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.
Haoyun ZHANG Assistant Professor, Ph.D principal investigator
University of Macau
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 Cognition Disorders in Old Age and Cognitive Decline, run by University of Macau at 1 site in Macau.
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 9 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 2 Feb 2024. 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 Macau. 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 Haoyun ZHANG Assistant Professor (+853 88229212, haoyunzhang@um.edu.mo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative Data for the Montreal Cognitive Assessment - Chinese (Hong Kong) version (time frame: From February 2024 to January 2026). The study lists 3 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 2 Feb 2024.