Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

Healthy Clinical Trial

Official title:

Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014893
• Other study ID #: 201900045
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: National Research Center for Rehabilitation Technical Aids
• Contact: Ying Wang
• Phone: 1058122921
• Email: CARM_AD[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
China	National Research Center for Rehabilitation Technical Aids	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
National Research Center for Rehabilitation Technical Aids	Beijing academy of science and technology, Beijing University of Chinese Medicine, Central South University, Nanjing Brain Hospital, The Third People's Hospital of Yunnan Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	Up to 24 months.
Primary	Change in Cognitive function (SCD-9)	The SCD-9 questionnaire is used to assess cognitive function of participants.	Change from Baseline Cognitive test results at 3 months.
Primary	Change in Cognitive function (MoCA)	The Montreal Cognitive Assessment test is used to assess cognitive function of participants.	Change from Baseline Cognitive test results at 3 months.
Primary	Change in Cognitive function (AD8)	The AD8 test is used to assess cognitive function of participants.	Change from Baseline Cognitive test results at 3 months.
Primary	Change in Cognitive function (CDR)	The Clinical Dementia Rating (CDR) test is used to assess cognitive function of participants.	Change from Baseline Cognitive test results at 3 months.
Secondary	Change in Physical capacity (TUG)	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.
Secondary	Change in Physical capacity (chair standing)	The 30-second chair standing test is used to evaluate physical capacity of participants.	Change from Baseline physical capacity test results at 3 months.