Clinical trial NCT06397469: Enhancing Attention and Wellbeing Using Digital Therapeutics
Official title: Optimizing a Closed-loop Digital Meditation Intervention for Remediating Cognitive Decline and Reducing Stress in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
MCI
Cognitive Decline
Keywords: healthy aging
attention
cognition
dementia
intervention
digital
behavioral
prevention
decline
stress reduction
Quality of life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-05-03
Enrollment: 4000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.


Eligibility criteria: Inclusion Criteria:

* 60+ years old (adult)
* English language fluency
* owning a smartphone or tablet

Exclusion Criteria:

* Under 60 years old (minor)

Primary outcomes:
measure: Change on the Mobile Continuous Performance Task (CPT) over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
Secondary outcomes:
measure: Change on the Adaptive Cognitive Evaluation (ACE) over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
Other outcomes:
measure: Mean Change on Everyday Cognition Scale (ECog)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on Pittsburgh Sleep Quality Index (sleep)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on Framingham Cardiovascular Risk Score
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on SF-36 (overall health)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on Cognitive Failures Questionnaire
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on Perceived Stress Scale
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on UCLA 3-item Loneliness Scale
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on GAD-7 (anxiety)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on PHQ-9 (depression)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
measure: Mean Change on Emotional Regulation Questionnaire
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Adam Gazzaley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: David Ziegler, PhD
role: PRINCIPAL_INVESTIGATOR
References: