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NCT Number: NCT06843824

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Alzheimer Disease Alzheimer's Disease(AD) Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Depression Depression/Anxiety Symptoms Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Subjective Cognitive Decrease (SCD) Tauopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychology, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100101, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a custom-made graphene therapy cap

Device

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.

A regular cap that generates heat

Device

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.

Primary outcomes

  1. SCD

    Time frame: 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.

  2. MCI/AD

    Time frame: 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 outcomes

  1. depression

    Time frame: 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.

  2. Anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Psychology, Chinese Academy of Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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