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Clinical Trials/NCT03197454
NCT03197454
Completed
Not Applicable

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

Posit Science Corporation2 sites in 1 country147 target enrollmentStarted: June 1, 2018Last updated:
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ConditionsAge-related Cognitive Decline

Overview

Phase
Not Applicable
Status
Completed
Enrollment
147
Locations
2
Primary Endpoint
Change in performance on global cognitive composite score
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Change in performance on global cognitive composite score

Time Frame: At 3 months and at 9 months

Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

Secondary Outcomes

  • Change in performance on memory(At 3 months and at 9 months)
  • Change in task-related brain activation(At 3 months)
  • Change in brain function(At 3 months)
  • Change in functional performance(At 3 months and at 9 months)
  • Change in Depressive Symptoms(At 3 months and at 9 months)
  • Change in performance on processing speed composite score(At 3 months and at 9 months)
  • Change in brain structure(At 3 months)
  • Change in performance on executive function(At 3 months and at 9 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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