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

NCT06335836 | Recruiting DMC

• 1 other identifier: 2024-SR-127
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Mild Cognitive Impairment (MCI)

  Incidence of Mild Cognitive Impairment (MCI)

  through study completion, an average of 1 year

• Incidence of Alzheimer's disease (AD)

  Incidence of Alzheimer's disease (AD)

  through study completion, an average of 1 year

Secondary Outcomes (16)

• AVLT-H

  through study completion, an average of 1 year

• MoCA

  through study completion, an average of 1 year

• WMS-RLM

  through study completion, an average of 1 year

• WDS

  through study completion, an average of 1 year

• VFT

  through study completion, an average of 1 year

Study Arms (2)

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

Behavioral: social isolation

nonSI group (non-social isolation group)

LSNS-6\>12

Interventions

social isolation BEHAVIORAL

social isolation (0≤LSNS-6≤12)

SI group (social isolation group)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were grouped as SCD when they reported cognitive decline compared with a previous state, whereas neuropsychological battery and other objective investigations (adjusted age, gender, and education) were normal, and criteria for MCI, dementia, or any other neurologic or psychiatric diseases that potentially cause cognitive complaints were not met.

You may qualify if:

• SCD
• Self-perceived continuous cognitive decline compared with the previous normal state, and is not related to acute events;
• After adjustment for age, gender, and years of education, the standard cognitive test is normal, or the diagnostic criteria for MCI are not met;
• Selected candidates can sign the informed consent form themselves.

You may not qualify if:

• (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)

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China, Jiangsu, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

venous blood： amyloid tau APOE genotyping

MeSH Terms

Conditions

Social Isolation; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Zhu Yi

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Zhu Yi

CONTACT

+86 137 0516 4030; ZhuYi1981@njmu.edu.cn

Shi Chunxu

CONTACT

+86 18625175592; scx_0212@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CN (1)