Clinical trial NCT02331784: Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
Official title: Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults, Aging Brain
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
First posted: 2015-01-06
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

1. Age 65-79 years at the time of consent
2. Fluent English speakers, to ensure reasonable results neuropsychological assessments
3. 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
4. No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores \>25

Exclusion Criteria:

1. Diagnosis with Alzheimer's disease or related dementias
2. Requiring caregiver assistance in dressing/personal hygiene
3. Medical conditions predisposing to imminent functional decline
4. Recent participation of computer-delivered cognitive training
5. 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.
6. Uncorrectable acuity greater than 20/40
7. Self-reported cardiovascular disease
8. Claustrophobia or any other contraindication to MRI scanning
9. Inability to complete a 1-hour MRI
10. 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)
11. History of brain surgery; removal of brain tissue; or history of stroke.

Primary outcomes:
measure: Changes in performance on global cognitive composite score
timeFrame: Baseline and at the completion of 10 weeks of training
Secondary outcomes:
measure: Changes in brain function
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in brain structure
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in task-related brain activation
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in performance on memory composite score
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in performance on executive function composite score
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in performance on processing speed composite score
timeFrame: Baseline and at the completion of 10 weeks of training
Other outcomes:
measure: Changes in Life Satisfaction
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in Perceived Stress
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in Self-Efficacy
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in Olfaction
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Changes in Standing Balance
timeFrame: Baseline and at the completion of 10 weeks of training
measure: Change in Physical Activity
timeFrame: Over 10 weeks
measure: Change in Diet
timeFrame: Over 10 weeks
measure: Change in Social Activity
timeFrame: Over 10 weeks
measure: Change in Functional Abilities
timeFrame: Over 10 weeks
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Posit Science
name: Hyunkyu Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: