Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

May 20, 2025 updated by: Pengxu Wei, National Research Center for Rehabilitation Technical Aids
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100176
        • Recruiting
        • National Research Center for Rehabilitation Technical Aids
        • Contact:
          • Ying Wang
          • Phone Number: 1059122921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group, without specific treatments
Experimental: Cognitive training
This group receives treatments to improve cognitive function.
Combination product: multi-modal targeted intervention (e.g., cognitive training, exercise, games)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Cognitive test results at 3 months.
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.
Change from Baseline Cognitive test results at 3 months.
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.
Change from Baseline Cognitive test results at 3 months.
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.
Change from Baseline Cognitive test results at 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline physical capacity test results at 3 months.
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.
Change from Baseline physical capacity test results at 3 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Rehabilitation Technical Aids

Collaborators

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

Investigators

  • Principal Investigator: Pengxu Wei, National Research Center for Rehabilitation Technical Aids

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201900045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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