Back to resultsPlasticity-based Adaptive Cognitive Remediation for Alzheimer Disease (PACR-AD)
Primary Purpose
Older Adults, Aging Brain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-based Software
Commercially available Video Game
Sponsored by
About this trial
This is an interventional basic science trial for Older Adults, Aging Brain
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)
- History of brain surgery; removal of brain tissue; or history of stroke.
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computerized Plasticity-based Software
Commercially available video game
Arm Description
Computerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session.
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..
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Changes in task-related brain activation
Change in functional connectivity and brain activation will be measured while performing Flanker Task.
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.
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.
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.
Full Information
NCT ID
NCT02331784
First Posted
December 18, 2014
Last Updated
April 17, 2019
Sponsor
Posit Science Corporation
Collaborators
University of Iowa
1. Study Identification
Unique Protocol Identification Number
NCT02331784
Brief Title
Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
Acronym
PACR-AD
Official Title
Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
University of Iowa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Adults, Aging Brain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized Plasticity-based Software
Arm Type
Experimental
Arm Description
Computerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session.
Arm Title
Commercially available video game
Arm Type
Active Comparator
Arm Description
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..
Intervention Type
Behavioral
Intervention Name(s)
Computerized Plasticity-based Software
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Commercially available Video Game
Intervention Description
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 Outcome Measure Information:
Title
Changes in performance on global cognitive composite score
Description
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
Time Frame
Baseline and at the completion of 10 weeks of training
Secondary Outcome Measure Information:
Title
Changes in brain function
Description
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.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in brain structure
Description
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.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in task-related brain activation
Description
Change in functional connectivity and brain activation will be measured while performing Flanker Task.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in performance on memory composite score
Description
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.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in performance on executive function composite score
Description
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.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in performance on processing speed composite score
Description
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.
Time Frame
Baseline and at the completion of 10 weeks of training
Other Pre-specified Outcome Measures:
Title
Changes in Life Satisfaction
Description
Change in life satisfaction will be measured using the age-adjusted score on General Life Satisfaction Survey from NIH Tool Box.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in Perceived Stress
Description
Change in stress will be measured using the age-adjusted score on Perceived Stress Survey from NIH Tool Box.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in Self-Efficacy
Description
Change in self-efficacy will be measured using the age-adjusted score on Self-Efficacy Survey from NIH Tool Box.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in Olfaction
Description
Changes in olfaction will be measured using the age-adjusted score on Odor Identification Test from NIH Tool Box.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Changes in Standing Balance
Description
Changes in standing balance will be measured using age-adjusted score on Standing Balance Test from NIH Tool Box.
Time Frame
Baseline and at the completion of 10 weeks of training
Title
Change in Physical Activity
Description
Change in total score based on weekly self-report dairy about physical activity over a 10 week period.
Time Frame
Over 10 weeks
Title
Change in Diet
Description
Change in total score based on weekly self-report dairy about diet over a 10 week period.
Time Frame
Over 10 weeks
Title
Change in Social Activity
Description
Change in total score based on weekly self-report dairy about social activity over a 10 week period.
Time Frame
Over 10 weeks
Title
Change in Functional Abilities
Description
Change in total score based on weekly self-report dairy about functional abilities over a 10 week period
Time Frame
Over 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
History of brain surgery; removal of brain tissue; or history of stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunkyu Lee, Ph.D.
Organizational Affiliation
Posit Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
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