Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults.

Aging Clinical Trial

Official title:

Establishing Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06239922
• Other study ID #: BSERE23-APP019-ICI
• Secondary ID: 0153/2022/A
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: January 2024
• Source: University of Macau
• Contact: Haoyun ZHANG Assistant Professor
• Phone: +853 88229212
• Email: haoyunzhang[@]um.edu.mo
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Cognition Disorders
• Cognition Disorders in Old Age
• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment

Locations

Country	Name	City	State
Macau	Centre for Cognitive and Brain Sciences of the University of Macau	Macao	Macao SAR

Sponsors (1)

Lead Sponsor	Collaborator
University of Macau

Country where clinical trial is conducted

Macau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From February 2024 to January 2026
Primary	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.	From February 2024 to January 2026
Primary	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.	From February 2024 to January 2026
Secondary	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.	From February 2024 to January 2026
Secondary	Cerebral Hemodynamics Assessed Through Functional Near-Infrared Spectroscopy (fNIRS)	fNIRS will be employed to measure cerebral blood flow and oxygenation during cognitive tasks.	From February 2024 to January 2026
Secondary	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.	From February 2024 to January 2026