Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

NCT05014893 | Recruiting DMC

• 1 other identifier: 201900045
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI); Subjective Cognitive Decline (SCD); Aging; Healthy

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• Change in Physical capacity (TUG)

  Change from Baseline physical capacity test results at 3 months.

• Change in Physical capacity (chair standing)

  Change from Baseline physical capacity test results at 3 months.

Other Outcomes (1)

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

  Up to 24 months.

Study Arms (2)

Control

NO INTERVENTION

Control group, without specific treatments

Cognitive training

EXPERIMENTAL

This group receives treatments to improve cognitive function.

Combination Product: multi-modal targeted intervention (e.g., cognitive training, exercise, games)

Interventions

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)

Cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Research Center for Rehabilitation Technical Aids: lead
• Nanjing Brain Hospital: collaborator
• The Third People's Hospital of Yunnan Province: collaborator
• Central South University: collaborator
• Beijing academy of science and technology: collaborator
• Beijing University of Chinese Medicine: collaborator

Study Sites (1)

National Research Center for Rehabilitation Technical Aids

Beijing, Beijing Municipality, 100176, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training; Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pengxu Wei

  National Research Center for Rehabilitation Technical Aids

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang

CONTACT

1058122921; CARM_AD@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 20, 2021
• Study Start: August 6, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)