Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02331784
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Posit Science Corporation

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.

Condition or disease Intervention/treatment Phase
Older Adults, Aging Brain Behavioral: Computerized Plasticity-based Software Behavioral: Commercially available Video Game Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
Study Start Date : April 2015
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331784


Locations
Layout table for location information
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Posit Science Corporation
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: Hyunkyu Lee, Ph.D. Posit Science

Layout table for additonal information
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02331784     History of Changes
Other Study ID Numbers: PSC-PACR-AD-01
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders