The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD)

NCT ID: NCT06335836

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 209 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2028-12-30

Brief Summary

The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD

1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD;

2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation;

3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions;

4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients.

Detailed Description

1. to explore the impact of social isolation on the risk of progression to MCI or AD in the SCD population.

1. A cohort study design was enrolled in the SCD population, assess the degree of social isolation, and analyze the impact of social isolation, an exposure factor, on the progression of SCD patients to MCI or AD by collecting 3-5 years follow-up data;

2. To analyze the interaction between the degree of social isolation of SCD patients and the connectivity characteristics of executive control, default network, and language network in the brain functional network.

2. the predictive effects of APOE-ε4 genotype, degree of social isolation, loneliness, and dual-task walking ability on the risk of SCD progression to MCI and AD in SCD population.

1. Using data from a cohort study, a prediction model of the SCD population with APOE-ε4 genotype, degree of social isolation, loneliness, dual-task walking parameter, degree of executive-control brain network connectivity, and degree of depression was developed to predict the risk of SCD progression to MCI and AD;

2. Use the above prediction model to apply to the clinic for prognostic prediction and individualized risk factor control in the SCD population.

Conditions

Social Isolation; SCD; Subjective Cognitive Decline; MCI; Mild Cognitive Impairment; AD; Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SI group (social isolation group)

The LSNS-6 was used for assessing social networks among older Chinese. Lubben suggested using a score of less than 12 as a clinical cutoff point of the LSNS-6 to indicate social isolation, which meant, on average, the respondents had less than two people to perform social integration functions.

0≤LSNS-6≤12

social isolation

Intervention Type: BEHAVIORAL

social isolation (0≤LSNS-6≤12)

nonSI group (non-social isolation group)

LSNS-6\>12

No interventions assigned to this group

Interventions

social isolation

social isolation (0≤LSNS-6≤12)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• SCD

1. Self-perceived continuous cognitive decline compared with the previous normal state, and is not related to acute events;

2. After adjustment for age, gender, and years of education, the standard cognitive test is normal, or the diagnostic criteria for MCI are not met;

3. Selected candidates can sign the informed consent form themselves.

Exclusion Criteria

• (a) Aged under 45 years or older than 85 years; (b) Vascular dementia or other central nervous system diseases; (c) Hachinski Ischemic Scale score > 4 points; (d); Unable to complete neuropsychological tests (e.g., blindness, deafness, severe language impairment); (e) Drug abuse or alcohol dependency within the last 6 months; (f) Current participation in other cognition studies; (g) Severe diabetes mellitus, or severe cardiovascular disease, cerebrovascular disease, liver diseases, kidney diseases, psychiatric disorders; (h) Contraindications to imaging techniques: claustrophobia, metallic implants (e.g., intracranial metal clips), electronic devices (e.g., cardiac pacemakers)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhu Yi

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhu Yi

Role: CONTACT

ZhuYi1981@njmu.edu.cn

+86 137 0516 4030

Shi Chunxu

Role: CONTACT

scx_0212@outlook.com

+86 18625175592

Facility Contacts

Zhu Yi

Role: primary

ZhuYi1981@njmu.edu.cn

+86 137 0516 4030

Shi Chunxu

Role: backup

scx_0212@outlook.com

+8618625175592

Other Identifiers

2024-SR-127

Identifier Type: OTHER

Identifier Source: secondary_id

2024-SR-127

Identifier Type: -

Identifier Source: org_study_id