Clinical trial NCT05446909: Preventing Cognitive Decline
Official title: Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mindfulness vs. health education
Primary purpose: PREVENTION

Brief summary: The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

Detailed description: Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).

Eligibility criteria: Inclusion Criteria:

* Able to read/understand English
* Normal performance using standardized cognitive tests
* Self-reported decline in cognitive capacity such as memory loss
* Eligible for non-invasive fMRI
* Willing to be randomized
* Free of any severe psychiatric diagnoses or medication that may affect participation

Exclusion Criteria:

* Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
* Unable to provide consent or understand study procedures due to mental illness or cognitive limitations
* Previous meditation experiences
* Evidence of illicit drug use
* Participants for blood draws weigh less than 110 lbs
* Metal or metallic materials in the body such as pacemaker

Primary outcomes:
measure: Percentage of Trials Correct On Working Memory Test
timeFrame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
measure: Intervention Effects on Cognitive Decline
timeFrame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
measure: Intervention Effects on Emotion Regulation
timeFrame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
measure: Intervention Effects on Mindfulness
timeFrame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Secondary outcomes:
measure: Intervention Effects on Brain Function
timeFrame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
measure: Intervention Effects on Brain White Matter
timeFrame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
measure: Intervention Effects on Brain Grey Matter
timeFrame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: YiYuan Tang
role: PRINCIPAL_INVESTIGATOR
References: