Older Adults, Aging Brain Clinical Trial
— PACR-ADOfficial title:
Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
| Verified date | April 2019 |
| Source | Posit Science Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | April 20, 2017 |
| Est. primary completion date | April 20, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years to 79 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Iowa | Iowa City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Posit Science Corporation | University of Iowa |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | Change in Diet | Change in total score based on weekly self-report dairy about diet over a 10 week period. | Over 10 weeks | |
| Other | 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 | |
| Other | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |