Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

Posit Science

Status: Completed

Conditions: Age-related Cognitive Decline

Treatments: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Commercially available computerized training

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03197454

PSC-0605-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

Active Comparator group

Description:

Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Treatment:

Other: Commercially available computerized training