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RecruitingNCT05014893Updated May 22, 2025

Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

An interventional study of multi-modal targeted intervention (e.g., cognitive training, exercise, games) in Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD) and Aging, sponsored by National Research Center for Rehabilitation Technical Aids. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by National Research Center for Rehabilitation Technical Aids · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment (MCI)
  • Subjective Cognitive Decline (SCD)
  • Aging
  • Healthy
03

In context

Cognitive Dysfunction

3,845 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 100 is above the median of 64 across 2,810 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

National Research Center for Rehabilitation Technical Aids is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Clinical diagnosis of dementia
  • Adults who cannot follow the protocal
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • 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)

Interventions

  • Combination productmulti-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)

06

What researchers measure

Primary outcomes

  1. Change in Cognitive function (SCD-9)

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

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

  2. Change in Cognitive function (MoCA)

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

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

  3. Change in Cognitive function (AD8)

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

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

  4. Change in Cognitive function (CDR)

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

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

Secondary outcomes

  1. Change in Physical capacity (TUG)

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

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

  2. Change in Physical capacity (chair standing)

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

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

Other outcomes

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

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

    Time frame: Up to 24 months.

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Study locations

1 of 1 sites recruiting
  • National Research Center for Rehabilitation Technical Aids
    Beijing, Beijing 100176, China
    • Ying Wang · Contact · 1059122921
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05014893
Lead sponsor
National Research Center for Rehabilitation Technical Aids
Collaborators
Nanjing Brain Hospital, The Third People's Hospital of Yunnan Province, Central South University, Beijing academy of science and technology, Beijing University of Chinese Medicine
Responsible party
Pengxu Wei (Director, National Research Center for Rehabilitation Technical Aids) — Principal investigator
First posted
Aug 20, 2021
Start date
Aug 6, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 22, 2025

Study contacts

Ying Wang
Contact
CARM_AD@aliyun.com
1058122921
Pengxu Wei
principal investigator · National Research Center for Rehabilitation Technical Aids

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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