Mild Cognitive Impairment (MCI)gait dementiaNCT07448909
Cognitive-Frailty Gait Biomechanics for Early Dementia Detection
An observational study of Mild Cognitive Impairment (MCI), run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2026to 31 Dec 2029
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: USM memory clinic
Who may be able to join
- Older adults aged 50 years and above
- Able to ambulate independently without the use of walking aids
- Must be able to understand instructions, communicate effectively
- Free from any acute or unstable medical conditions at the time of assessment.
- 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.
Who cannot join
- Present with any diagnosed neurological disorder such as stroke or Parkinson's disease
- History of psychiatric illness, including major depressive disorder.
- Individuals with uncontrolled cardiovascular, metabolic, or endocrine conditions
- Have significant visual, auditory, or musculoskeletal impairments that may influence gait performance
- Currently taking medications known to affect cognitive or motor function
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
School of Health Sciences
Kota Bharu, Kelantan, 16150
Asrenee Ab Razak, MD, PhD, +609-7676004, asrenee@usm.my
About this study
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Dementia, Physical function
- Medical subject headings
- Cognitive Dysfunction, Dementia
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 |
|---|---|---|
| MCI group | Older adults diagnosed with mild cognitive impairment (cases) | |
| Healthy control group | Cognitively healthy older adults without MCI (controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed during normal walking
Average gait speed measured during normal walking using motion capture analysis.
Unit of Measure:
Meters per second (m/s)
Measured: At baseline (single assessment)
Stride length during normal walking
Mean stride length measured during normal walking using motion capture analysis.
Unit of Measure:
Meters (m)
Measured: At baseline
Cadence during normal walking
Cadence measured during normal walking using motion capture analysis.
Unit of Measure:
Steps per minute (steps/min)
Measured: At baseline (single assessment)
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
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.
Measured: At baseline (single assessment)
Cognitive function assessed by the Mini-Mental State Examination (MMSE)
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.
Measured: At baseline (single assessment)
Secondary outcomes (3)
Handgrip strength
Maximum handgrip strength measured using a handheld dynamometer.
Unit of Measure:
Kilograms (kg)
Measured: At baseline
Serum brain-derived neurotrophic factor (BDNF) concentration
Serum brain-derived neurotrophic factor (BDNF) concentration measured from blood samples.
Unit of Measure:
ng/mL
Measured: At baseline
Functional mobility assessed by the Timed Up and Go test
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.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazlin Shaharudin, Universiti Sains Malaysia
- Investigators
- Shazlin Shaharudin, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448909
- Sponsor's protocol ID
- USM/JEPeM/KK/24080690
- Other IDs
- FRGS/1/2024/SKK05/USM/02/2
- Acronym
- gait dementia
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Frailty Gait Biomechanics for Early Dementia Detection
- ClinicalTrials.gov ID
- NCT07448909
- Acronym / sponsor ID
- gait dementia / USM/JEPeM/KK/24080690
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Dementia, Physical function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Mar 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI group | – | –Older adults diagnosed with mild cognitive impairment (cases) |
| Healthy control group | – | –Cognitively healthy older adults without MCI (controls) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- USM memory clinic
Key inclusion criteria (8 listed)
- Older adults aged 50 years and above
- Able to ambulate independently without the use of walking aids
- Must be able to understand instructions, communicate effectively
- Free from any acute or unstable medical conditions at the time of assessment.
- -No history or symptoms of cognitive impairments and have normal cognitive screening results.
Key exclusion criteria (6 listed)
- Present with any diagnosed neurological disorder such as stroke or Parkinson's disease
- History of psychiatric illness, including major depressive disorder.
- Individuals with uncontrolled cardiovascular, metabolic, or endocrine conditions
- Have significant visual, auditory, or musculoskeletal impairments that may influence gait performance
- Currently taking medications known to affect cognitive or motor function
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
Gait speed during normal walking
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)
Stride length during normal walking
Time frame: At baseline
Mean stride length measured during normal walking using motion capture analysis. Unit of Measure: Meters (m)
Cadence during normal walking
Time frame: At baseline (single assessment)
Cadence measured during normal walking using motion capture analysis. Unit of Measure: Steps per minute (steps/min)
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
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.
Cognitive function assessed by the Mini-Mental State Examination (MMSE)
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.
3 secondary outcomes
Handgrip strength
Time frame: At baseline
Serum brain-derived neurotrophic factor (BDNF) concentration
Time frame: At baseline
Functional mobility assessed by the Timed Up and Go test
Time frame: At baseline (single assessment)
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 4 Mar 2026.
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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.
Shazlin Shaharudin principal investigator
Universiti Sains Malaysia
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 Mild Cognitive Impairment (MCI), run by Universiti Sains Malaysia at 1 site in Malaysia.
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 8 inclusion and 6 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 4 Mar 2026. 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 Malaysia. 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 Shazlin Shaharudin, PhD (+609-767 7578, shazlin@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed during normal walking (time frame: At baseline (single assessment)). The study lists 5 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 4 Mar 2026.