Preventing Cognitive Decline

Cognitive Decline Clinical Trial

Official title:

Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446909
• Other study ID #: 2022 IBMT SCD
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• IBMT mindfulness
IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
• health education
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention effects on working memory	Changes in the composite measures of cognition such as N-back working memory; the minimum and maximum values (1 and 5); higher scores mean a better outcome.	The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Primary	Intervention effects on cognitive decline	Changes in the composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.	The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Primary	Intervention effects on emotion regulation	Changes in the composite measures of executive function such as emotion regulation questionnaire; the minimum and maximum values (4 and 10); higher scores mean a better outcome. questionnaire	The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Primary	Intervention effects on mindfulness	Changes in the composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (8 and 40); higher scores mean a better outcome.	The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Secondary	Intervention effects on brain function	AD-signature cortical connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting-state imaging	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Secondary	Intervention effects on brain white matter	AD-signature cortical white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Secondary	Intervention effects on brain grey matter	AD-signature cortical volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months