Back to resultsNeural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
Primary Purpose
Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Aging
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multi-modal targeted intervention (e.g., cognitive training, exercise, games)
Sponsored by
About this trial
This is an interventional screening trial for Mild Cognitive Impairment (MCI)
Eligibility Criteria
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
Sites / Locations
- National Research Center for Rehabilitation Technical AidsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Cognitive training
Arm Description
Control group, without specific treatments
This group receives treatments to improve cognitive function.
Outcomes
Primary Outcome Measures
Change in Cognitive function (SCD-9)
The SCD-9 questionnaire is used to assess cognitive function of participants.
Change in Cognitive function (MoCA)
The Montreal Cognitive Assessment test is used to assess cognitive function of participants.
Change in Cognitive function (AD8)
The AD8 test is used to assess cognitive function of participants.
Change in Cognitive function (CDR)
The Clinical Dementia Rating (CDR) test is used to assess cognitive function of participants.
Secondary Outcome Measures
Change in Physical capacity (TUG)
The timed up and go (TUG) test is used to evaluate physical capacity of participants.
Change in Physical capacity (chair standing)
The 30-second chair standing test is used to evaluate physical capacity of participants.
Full Information
NCT ID
NCT05014893
First Posted
August 1, 2021
Last Updated
September 27, 2022
Sponsor
National Research Center for Rehabilitation Technical Aids
1. Study Identification
Unique Protocol Identification Number
NCT05014893
Brief Title
Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
Official Title
Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center for Rehabilitation Technical Aids
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Cognitive assessment tools are used to assess cognitive function of the subjects, including those aged 60 or older. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Aging
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group, without specific treatments
Arm Title
Cognitive training
Arm Type
Experimental
Arm Description
This group receives treatments to improve cognitive function.
Intervention Type
Combination Product
Intervention Name(s)
multi-modal targeted intervention (e.g., cognitive training, exercise, games)
Intervention Description
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 Outcome Measure Information:
Title
Change in Cognitive function (SCD-9)
Description
The SCD-9 questionnaire is used to assess cognitive function of participants.
Time Frame
Change from Baseline Cognitive test results at 3 months.
Title
Change in Cognitive function (MoCA)
Description
The Montreal Cognitive Assessment test is used to assess cognitive function of participants.
Time Frame
Change from Baseline Cognitive test results at 3 months.
Title
Change in Cognitive function (AD8)
Description
The AD8 test is used to assess cognitive function of participants.
Time Frame
Change from Baseline Cognitive test results at 3 months.
Title
Change in Cognitive function (CDR)
Description
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 Outcome Measure Information:
Title
Change in Physical capacity (TUG)
Description
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.
Title
Change in Physical capacity (chair standing)
Description
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 Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
Up to 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang
Phone
1058122921
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pengxu Wei
Organizational Affiliation
National Research Center for Rehabilitation Technical Aids
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Center for Rehabilitation Technical Aids
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100176
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang
Phone
1059122921
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
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