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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment (MCI); Alzheimer's Disease(AD); Subjective Cognitive Decrease (SCD); Depression/Anxiety Symptoms
• Intervention / Treatment: Device: a custom-made graphene therapy cap; Device: A regular cap that generates heat

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100101
      • Institute of Psychology, Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Graphene far infrared intervention group; The intervention group used the Graphene Far Infrared Intervention (GFII), in which a caregiver who had undergone standardized training wore a graphene cap that could heat up to 40°C on the elderly. The cap was worn by the elderly for a fixed period of time each day and removed after approximately 40 minutes. During the time of wearing the cap, the elderly can perform any activity (e.g., reading the newspaper, watching TV) within the length of the power cord in a sitting, lying, standing position, etc.	Device: a custom-made graphene therapy cap; The GFII involved the use of a custom-made graphene therapy cap. The cap consisted of 3 parts: the main body of the cap, the thermostat and the power adapter. One end of the thermostat was connected to the main body of the cap, and the other end was connected to the power adapter; the adapter was plugged into a 220 V household power outlet. This turned on the cap, and the temperature could be adjusted. The light energy conversion rate of the graphene coating material used in the cap reached 90%, generating a temperature of 40 °C. Five caregivers were responsible for providing care for the elderly individuals. We will provided standardized training on the GFII to their caregivers. Each caregiver was responsible for assisting with the intervention of the elderly individuals that they usually cared for.
Placebo Comparator: Wear a normal heatable cap group; The placebo control group used ordinary hats that could be heated to about 40°C and were worn to the head of the elderly by caregivers who had undergone standardized training. The elderly wore the heat generating cap for a fixed period of time each day and removed it after about 40 minutes. During the period of wearing the cap, the elderly can sit, lie down, stand in the position of the length of the power cord, and carry out any activities (e.g., reading newspaper, watching TV)	Device: A regular cap that generates heat; The rest of the procedure is the same as the GFII group, but the cap used is a regular cap that can heat up to 40°C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCD	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.	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
MCI/AD	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).	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depression	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.	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	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.	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

Collaborators and Investigators

• Sponsor: Institute of Psychology, Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): May 11, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Older Adults; Randomized Controlled Trial (RCT); Mild cognitive impairment (MCI); Graphene Far Infrared Intervention (GFII); Subjective Cognitive Decrease (SCD); Alzheimer's Disease(AD)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Behavior; Anxiety Disorders; Cognitive Dysfunction; Alzheimer Disease; Depression
• Other Study ID Numbers: 2023YFC3605304-1; 2023YFC3605304 (Other Grant/Funding Number: National Key Research and Development projects)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No