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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-85
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

(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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • social isolation

    Behavioral

    social isolation (0≤LSNS-6≤12)

Treatment groups

209 Participants
are divided into 2 treatment groups
Group A: SI group (social isolation group)1 intervention
Group B: nonSI group (non-social isolation group)0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Mild Cognitive Impairment (MCI)

Incidence of Mild Cognitive Impairment (MCI)

Time frame
through study completion, an average of 1 year
2

Incidence of Alzheimer's disease (AD)

Incidence of Alzheimer's disease (AD)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

AVLT-H

Auditory Verbal Learning Test Huashan Version, AVLT-H The Auditory Verbal Learning Test-Huashan version (AVLT-H) assessment will be used as the primary outcome to assess EM for our study. The AVLT-H assesses several aspects of verbal EM through a list of 12 words, such as short or long-term delayed recall and recognition. It has been widely used as a semantic categorization memory test in mainland Chinese populations.

Time frame
through study completion, an average of 1 year
2

MoCA

Montreal Cognitive Assessment, MoCA Overall cognitive function will be assessed using scores from the Montreal Cognitive Assessment Test (MOCA).

Time frame
through study completion, an average of 1 year
3

WMS-RLM

Wechsler Memory Scale-Revised Logical Memory, WMS-RLM Participants were asked to recall the stories they had heard after listening to a short story containing 25 information points, with 1 point for each information point and 25 points for each story, for a total of two stories out of 50 points, with higher scores indicating better short-term memory.

Time frame
through study completion, an average of 1 year
4

WDS

Wechsler Digit Span, WDS The scale is divided into two parts, forward numerical memory and inverse numerical memory, with 12 items each, with a maximum of 12 points and a maximum score of 24 points, with higher scores leading to better short-term memory and attention.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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