University of Iowa
Iowa City, Iowa, 52242, United States
NCT Number: NCT02331784
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.
Looking for future studies?
Notify Me65 year–79 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Over 10 weeks
Change in total score based on weekly self-report dairy about physical activity over a 10 week period.
Time frame: Over 10 weeks
Change in total score based on weekly self-report dairy about diet over a 10 week period.
Time frame: Over 10 weeks
Change in total score based on weekly self-report dairy about social activity over a 10 week period.
Time frame: Over 10 weeks
Change in total score based on weekly self-report dairy about functional abilities over a 10 week period
Posit Science Corporation
Industry
Acronym: PACR-AD
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.
Published trials that share one or more normalized conditions with this study.
NCT07244562
Elderly, Older Adults, Aging Brain
Ferrara, Italy
View Trial Details