Age-related Cognitive Decline
Conditions
Brief summary
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
Detailed description
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.
Interventions
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
Forty-two minutes of training on computerized, casual video games.
Sponsors
University of Iowa
The University of Texas at Dallas
National Institute on Aging (NIA)
Posit Science Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 65 years of age or older * Participant must be a fluent English speaker * Participant must have 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 * Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)
Exclusion criteria
* Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline * Participant requiring caregiver assistance in dressing/personal hygiene * Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program * Participant with recent participation of computer-delivered cognitive training within 2 years of consent * Participant with claustrophobia or any other contraindication to MRI scanning * Participant with inability to complete a 1-hour MRI * Pregnant women * Participant with 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) * Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in performance on global cognitive composite score | At 3 months and at 9 months | Change in performance on global cognitive composite score based on the average of all normalized assessment measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in performance on processing speed composite score | At 3 months and at 9 months | 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. |
| Change in performance on memory | At 3 months and at 9 months | Change in performance on memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task, Face Name Task, and Visual Short Term Memory tasks. |
| Change in performance on executive function | At 3 months and at 9 months | Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task, N-Back Task and Task Switch (fMRI task). |
| Change in brain function | At 3 months | 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. |
| Change in brain structure | At 3 months | 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. |
| Change in task-related brain activation | At 3 months | Change in functional connectivity and brain activation will be measured while performing Task Switch. |
| Change in functional performance | At 3 months and at 9 months | Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance. |
| Change in Depressive Symptoms | At 3 months and at 9 months | Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy | At 3 months and at 9 months | Between-group magnitude of change in sum score using the self-report measure, Self-Efficacy Survey. The scoring range is 10-40. Lower scores indicate lower self efficacy. |
| Change in Life Satisfaction | At 3 months and at 9 months | Between-group magnitude of change in sum score using the self-report measure, Life Satisfaction Scale. The scoring range is 5-35. Lower scores indicate lower life satisfaction. |
| Change in Physical Activity | At 3 months | Change in total score based on weekly self-report dairy about physical activity during training period. |
| Change in Diet | At 3 months | Change in total score based on weekly self-report dairy about diet during training period. |
| Change in Social Activity | At 3 months | Change in total score based on weekly self-report dairy about social activity during training period. |
| Change in Sleep | At 3 months | Change in total score based on weekly self-report dairy about sleep during training period. |
| Change in Functional Abilities | At 3 months | Change in total score based on weekly self-report dairy about functional abilities during training period. |
| Change in Stress | At 3 months and at 9 months | Between-group magnitude of change in sum score using the self-report measure, Perceived Stress Scale (PSS-10). The scoring range is 0-40. Higher scores indicate higher perceived stress. |
Countries
United States
Outcome results
None listed