- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06239922
Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults.
Establishing Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Haoyun ZHANG Assistant Professor
- Phone Number: +853 88229212
- Email: haoyunzhang@um.edu.mo
Study Contact Backup
- Name: LEI KEI KEI research assistant, MSc
- Phone Number: +853 88229198
- Email: keikeilei@umac.mo
Study Locations
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Macao SAR
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Macao, Macao SAR, Macau, 999078
- Centre for Cognitive and Brain Sciences of the University of Macau
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Contact:
- Haoyun ZHANG Assistant Professor
- Phone Number: +853 88229212
- Email: haoyunzhang@um.edu.mo
-
Contact:
- LEI KEI KEI Research Assistant, MSc
- Phone Number: +853 8822 9198
- Email: keikeilei@umac.mo
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Principal Investigator:
- Haoyun ZHANG Assistant Professor, Ph.D
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnancy
- Being under the legal age of adulthood (children)
- Incarcerated individuals (prisoners)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Older adults
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Group 2
Younger adults
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normative Data for the Montreal Cognitive Assessment - Chinese (Hong Kong) version
Time Frame: From February 2024 to January 2026
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The MoCA will be administered to derive a normative data set representative of the older adult population in Macau.
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From February 2024 to January 2026
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Normative Data for the Mini-Mental State Examination (MMSE)
Time Frame: From February 2024 to January 2026
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The MMSE will be administered to derive a normative data set representative of the older adult population in Macau.
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From February 2024 to January 2026
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Normative Scores for Computerized Neuropsychological Tasks
Time Frame: From February 2024 to January 2026
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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.
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From February 2024 to January 2026
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural Activation Patterns During Cognitive Tasks as Revealed by Functional Magnetic Resonance Imaging (fMRI)
Time Frame: From February 2024 to January 2026
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fMRI data will be collected to identify patterns of neural activation associated with cognitive task performance.
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From February 2024 to January 2026
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Cerebral Hemodynamics Assessed Through Functional Near-Infrared Spectroscopy (fNIRS)
Time Frame: From February 2024 to January 2026
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fNIRS will be employed to measure cerebral blood flow and oxygenation during cognitive tasks.
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From February 2024 to January 2026
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Electrophysiological Correlates of Cognitive Activity as Measured by Electroencephalography (EEG)
Time Frame: From February 2024 to January 2026
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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.
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From February 2024 to January 2026
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Haoyun ZHANG Assistant Professor, Ph.D, University of Macau
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSERE23-APP019-ICI
- 0153/2022/A (Other Grant/Funding Number: The Science and Technology Development Fund (FDCT)of the Macao Special Administrative Region (SAR))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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