Clinical trial NCT06843824: A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults
Official title: A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Subjective Cognitive Decrease (SCD)
Alzheimer's Disease(AD)
Depression/Anxiety Symptoms
Keywords: Graphene Far Infrared Intervention (GFII)
Randomized Controlled Trial (RCT)
Older Adults
Subjective Cognitive Decrease (SCD)
Mild cognitive impairment (MCI)
Alzheimer&#39;s Disease(AD)
Lead sponsor: Institute of Psychology, Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: SCD
timeFrame: 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
measure: MCI/AD
timeFrame: 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 outcomes:
measure: depression
timeFrame: 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
measure: Anxiety
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Psychology, Chinese Academy of Sciences
state: Beijing
Study officials:
References: