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Completed

NCT Number: NCT02331784

Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease

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.

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Key information

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • History of brain surgery; removal of brain tissue; or history of stroke.

Treatment and study plan

Computerized Plasticity-based Software

Behavioral

Participants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).

Commercially available Video Game

Behavioral

Participants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).

Primary outcomes

  1. 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

  1. Changes in brain function

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

    Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.

  2. Changes in brain structure

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

    3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.

  3. Changes in task-related brain activation

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

    Change in functional connectivity and brain activation will be measured while performing Flanker Task.

  4. Changes in performance on memory composite score

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

    Change in performance on memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory, Spatial Working Memory and N-Back tasks.

  5. Changes in performance on executive function composite score

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

    Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Flanker, Stroop and Trail Making tasks.

  6. Changes in performance on processing speed composite score

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

    Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.

Other outcomes

  1. Changes in Life Satisfaction

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

    Change in life satisfaction will be measured using the age-adjusted score on General Life Satisfaction Survey from NIH Tool Box.

  2. Changes in Perceived Stress

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

    Change in stress will be measured using the age-adjusted score on Perceived Stress Survey from NIH Tool Box.

  3. Changes in Self-Efficacy

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

    Change in self-efficacy will be measured using the age-adjusted score on Self-Efficacy Survey from NIH Tool Box.

  4. Changes in Olfaction

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

    Changes in olfaction will be measured using the age-adjusted score on Odor Identification Test from NIH Tool Box.

  5. Changes in Standing Balance

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

    Changes in standing balance will be measured using age-adjusted score on Standing Balance Test from NIH Tool Box.

  6. Change in Physical Activity

    Time frame: Over 10 weeks

    Change in total score based on weekly self-report dairy about physical activity over a 10 week period.

  7. Change in Diet

    Time frame: Over 10 weeks

    Change in total score based on weekly self-report dairy about diet over a 10 week period.

  8. Change in Social Activity

    Time frame: Over 10 weeks

    Change in total score based on weekly self-report dairy about social activity over a 10 week period.

  9. Change in Functional Abilities

    Time frame: Over 10 weeks

    Change in total score based on weekly self-report dairy about functional abilities over a 10 week period

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • University of Iowa

Registry information

Acronym: PACR-AD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2015
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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