Clinical trial NCT03197454: Brain Enhancement Training Towards Elders Resilience to Aging
Official title: Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
name: The University of Texas at Dallas
name: National Institute on Aging (NIA)
First posted: 2017-06-23
Enrollment: 147
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Detailed description: The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

Eligibility criteria: Inclusion Criteria:

* Participant must be 65 years of age or older
* Participant must be a fluent English speaker
* Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
* Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

* Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline
* Participant requiring caregiver assistance in dressing/personal hygiene
* Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program
* Participant with recent participation of computer-delivered cognitive training within 2 years of consent
* Participant with claustrophobia or any other contraindication to MRI scanning
* Participant with inability to complete a 1-hour MRI
* Pregnant women
* Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
* Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Primary outcomes:
measure: Change in performance on global cognitive composite score
timeFrame: At 3 months and at 9 months
Secondary outcomes:
measure: Change in performance on processing speed composite score
timeFrame: At 3 months and at 9 months
measure: Change in performance on memory
timeFrame: At 3 months and at 9 months
measure: Change in performance on executive function
timeFrame: At 3 months and at 9 months
measure: Change in brain function
timeFrame: At 3 months
measure: Change in brain structure
timeFrame: At 3 months
measure: Change in task-related brain activation
timeFrame: At 3 months
measure: Change in functional performance
timeFrame: At 3 months and at 9 months
measure: Change in Depressive Symptoms
timeFrame: At 3 months and at 9 months
Other outcomes:
measure: Change in Stress
timeFrame: At 3 months and at 9 months
measure: Change in Self-Efficacy
timeFrame: At 3 months and at 9 months
measure: Change in Life Satisfaction
timeFrame: At 3 months and at 9 months
measure: Change in Physical Activity
timeFrame: At 3 months
measure: Change in Diet
timeFrame: At 3 months
measure: Change in Social Activity
timeFrame: At 3 months
measure: Change in Sleep
timeFrame: At 3 months
measure: Change in Functional Abilities
timeFrame: At 3 months
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Dallas
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: Posit Science Corporation
name: Hyun Kyu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: