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Clinical Trials/NCT02331784
NCT02331784
Completed
Not Applicable

Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease

Posit Science Corporation1 site in 1 country68 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Older Adults, Aging Brain
Sponsor
Posit Science Corporation
Enrollment
68
Locations
1
Primary Endpoint
Changes in performance on global cognitive composite score
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

The normal aging has a devastating effect on our cognitive ability to learn and remember, on the speed with which the investigators process information, and on our ability to reason. By 2050, nearly 14 million individuals in the US will be living with Alzheimer's disease (AD), up from 5 million in 2013. AD is the most common cause of dementia, resulting in the loss of cognitive functions such as memory, reasoning, language, and cognitive, social, physical, and emotional control, to the extent that losses interfere with activities of daily living and necessitate continuous monitoring and care. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with aging brain.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 20, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 65-79 years at the time of consent
  • Fluent English speakers, to ensure reasonable results neuropsychological assessments
  • 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
  • No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores \>25

Exclusion Criteria

  • Diagnosis with Alzheimer's disease or related dementias
  • Requiring caregiver assistance in dressing/personal hygiene
  • Medical conditions predisposing to imminent functional decline
  • Recent participation of computer-delivered cognitive training
  • Diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) will be excluded due to the confound with cognitive impairment from normal aging.
  • Uncorrectable acuity greater than 20/40
  • Self-reported cardiovascular disease
  • Claustrophobia or any other contraindication to MRI scanning
  • Inability to complete a 1-hour MRI
  • 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)

Outcomes

Primary Outcomes

Changes in performance on global cognitive composite score

Time Frame: Baseline and at the completion of 10 weeks of training

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

Secondary Outcomes

  • Changes in brain function(Baseline and at the completion of 10 weeks of training)
  • Changes in brain structure(Baseline and at the completion of 10 weeks of training)
  • Changes in task-related brain activation(Baseline and at the completion of 10 weeks of training)
  • Changes in performance on memory composite score(Baseline and at the completion of 10 weeks of training)
  • Changes in performance on executive function composite score(Baseline and at the completion of 10 weeks of training)
  • Changes in performance on processing speed composite score(Baseline and at the completion of 10 weeks of training)

Study Sites (1)

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