School of Health Sciences
Kota Bharu, Kelantan, 16150, Malaysia
NCT Number: NCT07448909
The purpose of this study is to better understand how physical characteristics, walking patterns, and a blood-based brain health marker differ between older adults with dementia and healthy older adults.
Dementia is often associated with changes in physical health and movement, but these changes are not fully understood. This study asks whether people with dementia show differences in body composition, walking ability, and levels of brain-derived neurotrophic factor (BDNF), a protein involved in brain function, compared with individuals without dementia.
To answer this question, participants will complete a single assessment session that includes basic physical measurements, an assessment of walking while moving at a comfortable pace, and a small blood sample collection. The information collected will be used to compare the two groups and explore possible relationships between physical function, walking patterns, and BDNF levels.
Trial opening soon.
Get Notified50 year and older
All sexes
Observational
Kota Bharu, Kelantan, 16150, Malaysia
This observational, cross-sectional comparative study is designed to characterize differences in physical measurements, gait parameters, and circulating brain-derived neurotrophic factor (BDNF) levels between individuals with dementia and cognitively healthy older adults.
All data will be collected during a single study visit using standardized procedures. Physical and physiological measurements will be obtained following established protocols to ensure consistency across participants. Gait data will be captured using two-dimensional video-based motion capture and analyzed using validated software to extract spatiotemporal gait parameters. Calibration procedures will be performed prior to data collection to ensure measurement accuracy.
Venous blood samples will be collected by trained personnel and processed according to laboratory standard operating procedures to obtain plasma and serum. Samples will be stored and analyzed under controlled conditions using standardized assays for the quantification of BDNF.
Data quality will be ensured through predefined data entry procedures, range and consistency checks, and verification of source data against original measurement records. All collected data will be anonymized and stored in a secure database accessible only to authorized study personnel. Any missing or incomplete data will be documented, and analyses will be conducted using appropriate statistical methods to account for missing values.
The sample size is determined based on feasibility and prior literature involving similar observational comparisons. Statistical analyses will focus on descriptive and inferential comparisons between study groups, using appropriate parametric or non-parametric methods depending on data distribution. Multivariable analyses may be performed to account for relevant covariates. Statistical significance will be assessed using a predefined alpha level.
No study interventions will be administered, and participants will not undergo longitudinal follow-up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy older adults group:
-No history or symptoms of cognitive impairments and have normal cognitive screening results.
Mild Cognitive Impairment (MCI) group:
-Must fulfill established diagnostic criteria for MCI, showing measurable cognitive decline without significant functional impairment and without a diagnosis of dementia.
Exclusion criteria
Time frame: At baseline (single assessment)
Average gait speed measured during normal walking using motion capture analysis.
Unit of Measure:
Meters per second (m/s)
Time frame: At baseline
Mean stride length measured during normal walking using motion capture analysis.
Unit of Measure:
Meters (m)
Time frame: At baseline (single assessment)
Cadence measured during normal walking using motion capture analysis.
Unit of Measure:
Steps per minute (steps/min)
Time frame: At baseline (single assessment)
Global cognitive function measured using the Montreal Cognitive Assessment (MoCA), a standardized cognitive screening tool assessing multiple cognitive domains.
Unit of Measure:
Score on a scale
Scale Description:
Montreal Cognitive Assessment (MoCA) total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame: At baseline (single assessment)
Global cognitive function measured using the Mini-Mental State Examination (MMSE), a standardized cognitive screening instrument.
Unit of Measure:
Score on a scale
Scale Description:
Mini-Mental State Examination (MMSE) total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame: At baseline
Maximum handgrip strength measured using a handheld dynamometer.
Unit of Measure:
Kilograms (kg)
Time frame: At baseline
Serum brain-derived neurotrophic factor (BDNF) concentration measured from blood samples.
Unit of Measure:
ng/mL
Time frame: At baseline (single assessment)
Functional mobility measured using the Timed Up and Go (TUG) test, which assesses the time required to stand up from a chair, walk 3 meters, turn, return, and sit down.
Unit of Measure:
Seconds (s)
Directionality:
Lower values indicate better functional mobility.
Contact information is provided by the study sponsor or research team.
Universiti Sains Malaysia
Other
Acronym: gait dementia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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