Mild Cognitive Impairment (MCI)NCT05014893
Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
A study testing multi-modal targeted intervention (e.g., cognitive training, exercise, games) in people with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD), run by National Research Center for Rehabilitation Technical Aids at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Aging
- What is being tested?
- multi-modal targeted intervention (e.g., cognitive training, exercise, games)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2021to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical diagnosis of dementia
- Adults who cannot follow the protocal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Research Center for Rehabilitation Technical Aids
Beijing, Beijing Municipality, 100176
Ying Wang, 1059122921
About this study
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.
- Being tested
- multi-modal targeted intervention (e.g., cognitive training, exercise, games)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group, without specific treatments |
| Cognitive training | Experimental | This group receives treatments to improve cognitive function. Receives: Combination Product: multi-modal targeted intervention (e.g., cognitive training, exercise, games) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive function (SCD-9)
The SCD-9 questionnaire is used to assess cognitive function of participants.
Measured: Change from Baseline Cognitive test results at 3 months.
Change in Cognitive function (MoCA)
The Montreal Cognitive Assessment test is used to assess cognitive function of participants.
Measured: Change from Baseline Cognitive test results at 3 months.
Change in Cognitive function (AD8)
The AD8 test is used to assess cognitive function of participants.
Measured: Change from Baseline Cognitive test results at 3 months.
Change in Cognitive function (CDR)
The Clinical Dementia Rating (CDR) test is used to assess cognitive function of participants.
Measured: Change from Baseline Cognitive test results at 3 months.
Secondary outcomes (2)
Change in Physical capacity (TUG)
The timed up and go (TUG) test is used to evaluate physical capacity of participants.
Measured: Change from Baseline physical capacity test results at 3 months.
Change in Physical capacity (chair standing)
The 30-second chair standing test is used to evaluate physical capacity of participants.
Measured: Change from Baseline physical capacity test results at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start6 Aug 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Rehabilitation Technical Aids
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Pengxu Wei, National Research Center for Rehabilitation Technical Aids
- Investigators
- Pengxu Wei, Principal investigator, National Research Center for Rehabilitation Technical Aids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014893
- Sponsor's protocol ID
- 201900045
- Status last verified
- May 2025
- First submitted
- 1 Aug 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
- ClinicalTrials.gov ID
- NCT05014893
- Acronym / sponsor ID
- 201900045
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center for Rehabilitation Technical AidsUniversity, hospital or other
- 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
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2021 (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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group, without specific treatments |
| Cognitive training | Experimental | Combination Product: multi-modal targeted intervention (e.g., cognitive training, exercise, games)This group receives treatments to improve cognitive function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Clinical diagnosis of dementia
- Adults who cannot follow the protocal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Combination product | Cognitive training |
Primary outcome
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 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 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 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.
2 secondary outcomes
Change in Physical capacity (TUG)
Time frame: 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.
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 22 May 2025.
- Individual participant dataSharing planned: No
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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.
Pengxu Wei principal investigator
National Research Center for Rehabilitation Technical Aids
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-modal targeted intervention (e.g., cognitive training, exercise, games) in people with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD), run by National Research Center for Rehabilitation Technical Aids at 1 site in China.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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 China. 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 Ying Wang (1058122921, CARM_AD@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive function (SCD-9) (time frame: Change from Baseline Cognitive test results at 3 months.). The study lists 4 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 22 May 2025.