A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults

Not Applicable

Active, not recruiting

• Conditions: Mild Cognitive Impairment (MCI); Subjective Cognitive Decrease (SCD); Alzheimer's Disease(AD); Depression/Anxiety Symptoms

• Registration Number: NCT06843824
• Lead Sponsor: Institute of Psychology, Chinese Academy of Sciences

Brief Summary

This study is a 4-week group controlled trial to explore whether graphene far-infrared intervention can improve the cognitive status of older adults presenting with symptoms of Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), or Alzheimer's Disease (AD), and is dedicated to enhancing the cognitive status of older adults and improving their mental health. Participants were older adults who presented with cognitive problems. Participants were divided into SCD and MCI/AD groups based on their cognitive level, and each group was further divided into a graphene far-infrared intervention group and a placebo control group. We also measured the depression and anxiety levels of the older adults and incidentally observed whether the graphene far-infrared intervention could have a positive impact on their mental health outcomes, which was not the focus of our study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-25
• Study Start: 2025-03-10
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age 55 years and above (age limit may be relaxed to not less than 45 years if there is a special desire to participate in the intervention)
• No barriers to daily communication
• Individuals participating voluntarily

Exclusion Criteria

• Good cognitive functioning (SCD score of 0)
• Subjective desire to withdraw
• Individuals who reported discomfort opting out during the experimental procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SCD	Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea	Depression was assessed by the Self-Rating Scale for Subjective Cognitive Decrease (SCD). The scale consists of 10 items that are scored from 1 (no change) to 3 (significant increase) based on the patient's self-reported subjective cognitive decompensation. A higher total score indicates more severe subjective cognitive decompensation.
MCI/AD	Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea	Cognitive function was assessed with the short form of the Montreal Cognitive Assessment (s-MoCA). The items are used to examine function in 6 cognitive domains (i.e., visuospatial/executive function, attention, language, abstraction, delayed memory, and orientation). If the number of years of education is less than or equal to 12, the total score is increased by 1 point. The total score ranges from 0 to 18: scores less than or equal to 11 indicate probable mild cognitive impairment (MCI), and scores less than or equal to 4 indicate probable Alzheimer's disease (AD).

Secondary Outcome Measures

Name	Time	Method
depression	Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea	Depression was assessed with the Patient Health Questionnaire (PHQ-9). The PHQ-9 contains nine items scored on a scale from 0 (not at all) to 3 (almost every day) based on the self-reported frequency of depressive symptoms in the past 2 weeks. The total score ranges from 0 to 27, and scores above 10 indicate probable depression symptoms.
Anxiety	Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea	Anxiety was assessed with the Chinese version of the Generalized Anxiety Disorder Scale (GAD-7). The 7 items are rated on a 4-point scale ranging from 0 (never) to 3 (almost every day) to assess the frequency of anxiety symptoms in the past 2 weeks. The total score ranges from 0 to 21, and according to the established criteria, scores above 10 indicate probable anxiety symptoms.

Trial Locations

Locations (1)

Institute of Psychology, Chinese Academy of Sciences; 🇨🇳 Beijing, Beijing, China