Cognitive-Frailty Gait Biomechanics for Early Dementia Detection

NCT07448909 | Not Yet Recruiting DMC

• 2 other identifiers: USM/JEPeM/KK/24080690FRGS/1/2024/SKK05/USM/02/2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Dementia; Physical function

Outcome Measures

Primary Outcomes (5)

• Gait speed during normal walking

  Average gait speed measured during normal walking using motion capture analysis. Unit of Measure: Meters per second (m/s)

  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)

  At baseline

• Cadence during normal walking

  Cadence measured during normal walking using motion capture analysis. Unit of Measure: Steps per minute (steps/min)

  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.

  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.

  At baseline (single assessment)

Secondary Outcomes (3)

• Handgrip strength

  At baseline

• Serum brain-derived neurotrophic factor (BDNF) concentration

  At baseline

• Functional mobility assessed by the Timed Up and Go test

  At baseline (single assessment)

Study Arms (2)

MCI group

Older adults diagnosed with mild cognitive impairment (cases)

Healthy control group

Cognitively healthy older adults without MCI (controls)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

USM memory clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

School of Health Sciences

Kota Bharu, Kelantan, 16150, Malaysia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood: Serum and plasma for BDNF analysis

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shazlin Shaharudin

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shazlin Shaharudin, PhD

CONTACT

+609-767 7578; shazlin@usm.my

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Ts Dr

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: March 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 4, 2026

Record last verified: 2025-12

Locations

MY (1)