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NCT Number: NCT05014893

Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

This study investigates the neural mechanisms of cognitive function decline, cognitive assessment methods for subjects with mild cognitive dysfunction (Mild cognitive impairment, MCI, or cognitive decline milder than MCI), and the approaches used to improve and restore cognitive function.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Aging Cognition Disorders Cognitive Dysfunction Healthy Mental Disorders Neurocognitive Disorders Subjective Cognitive Decline (SCD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Center for Rehabilitation Technical Aids

Beijing, Beijing Municipality, 100176, China

Location status: Recruiting

Location contact

Ying Wang

CONTACT

1059122921

About this study

Cognitive assessment tools are used to assess cognitive function of subjects in different cities. Functional and structural MRI and EEG are applied to investigate the neural mechanisms of cognitive function decline and effects of methods to improve and restore cognitive function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults being able to walk at least a block, and
  • Adults with subjective cognitive decline (SCD), or
  • Adults with mild cognitive impairment (MCI), or
  • Adults with normal cognitive function

Exclusion criteria

  • Clinical diagnosis of dementia
  • Adults who cannot follow the protocal

Treatment and study plan

multi-modal targeted intervention (e.g., cognitive training, exercise, games)

Combination Product

The Intervention group will be given recommended interventions tailored to individuals based on their risks (e.g., physical exercise programs, cognitive training, dietary advice, control of blood pressure and cholesterol, healthy diet, control obesity, stop smoking,reduce alcohol excess)

Primary outcomes

  1. Change in Cognitive function (SCD-9)

    Time frame: Change from Baseline Cognitive test results at 3 months.

    The SCD-9 questionnaire is used to assess cognitive function of participants.

  2. Change in Cognitive function (MoCA)

    Time frame: Change from Baseline Cognitive test results at 3 months.

    The Montreal Cognitive Assessment test is used to assess cognitive function of participants.

  3. Change in Cognitive function (AD8)

    Time frame: Change from Baseline Cognitive test results at 3 months.

    The AD8 test is used to assess cognitive function of participants.

  4. Change in Cognitive function (CDR)

    Time frame: Change from Baseline Cognitive test results at 3 months.

    The Clinical Dementia Rating (CDR) test is used to assess cognitive function of participants.

Secondary outcomes

  1. Change in Physical capacity (TUG)

    Time frame: Change from Baseline physical capacity test results at 3 months.

    The timed up and go (TUG) test is used to evaluate physical capacity of participants.

  2. Change in Physical capacity (chair standing)

    Time frame: Change from Baseline physical capacity test results at 3 months.

    The 30-second chair standing test is used to evaluate physical capacity of participants.

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Up to 24 months.

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Wang

CONTACT

[email protected]

1058122921

Sponsors and collaborators

Lead sponsor

National Research Center for Rehabilitation Technical Aids

Other

Collaborators

  • Beijing University of Chinese Medicine
  • Beijing academy of science and technology
  • Central South University
  • Nanjing Brain Hospital
  • The Third People's Hospital of Yunnan Province

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2021
Registry last updated
May 22, 2025

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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