Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease (PACR-AD)

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 Overview

• Status: Completed
• Conditions: Older Adults, Aging Brain
• Intervention / Treatment: Behavioral: Computerized Plasticity-based Software; Behavioral: Commercially available Video Game

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 79 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized Plasticity-based Software; Computerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session.	Behavioral: Computerized Plasticity-based Software; 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).
Active Comparator: Commercially available video game; Commercially available video game training. Treatment is software based, will occur up to 50 times throughout study duration, 4-5 times per week, 40 minutes each session..	Behavioral: Commercially available Video Game; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in performance on global cognitive composite score	Change in performance on global cognitive composite score based on the average of all normalized assessment measures.	Baseline and at the completion of 10 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain function	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.	Baseline and at the completion of 10 weeks of training
Changes in brain structure	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.	Baseline and at the completion of 10 weeks of training
Changes in task-related brain activation	Change in functional connectivity and brain activation will be measured while performing Flanker Task.	Baseline and at the completion of 10 weeks of training
Changes in performance on memory composite score	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.	Baseline and at the completion of 10 weeks of training
Changes in performance on executive function composite score	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.	Baseline and at the completion of 10 weeks of training
Changes in performance on processing speed composite score	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.	Baseline and at the completion of 10 weeks of training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Life Satisfaction	Change in life satisfaction will be measured using the age-adjusted score on General Life Satisfaction Survey from NIH Tool Box.	Baseline and at the completion of 10 weeks of training
Changes in Perceived Stress	Change in stress will be measured using the age-adjusted score on Perceived Stress Survey from NIH Tool Box.	Baseline and at the completion of 10 weeks of training
Changes in Self-Efficacy	Change in self-efficacy will be measured using the age-adjusted score on Self-Efficacy Survey from NIH Tool Box.	Baseline and at the completion of 10 weeks of training
Changes in Olfaction	Changes in olfaction will be measured using the age-adjusted score on Odor Identification Test from NIH Tool Box.	Baseline and at the completion of 10 weeks of training
Changes in Standing Balance	Changes in standing balance will be measured using age-adjusted score on Standing Balance Test from NIH Tool Box.	Baseline and at the completion of 10 weeks of training
Change in Physical Activity	Change in total score based on weekly self-report dairy about physical activity over a 10 week period.	Over 10 weeks
Change in Diet	Change in total score based on weekly self-report dairy about diet over a 10 week period.	Over 10 weeks
Change in Social Activity	Change in total score based on weekly self-report dairy about social activity over a 10 week period.	Over 10 weeks
Change in Functional Abilities	Change in total score based on weekly self-report dairy about functional abilities over a 10 week period	Over 10 weeks

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: University of Iowa
• Investigators: Principal Investigator: Hyunkyu Lee, Ph.D., Posit Science

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): April 20, 2017

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: PSC-PACR-AD-01