University of South Florida
Jennifer L. O'Brien
Dementia is the most expensive medical condition in the US and increases in prevalence with age. More than 5 million Americans have Alzheimer's disease, the most common form of dementia. Mild cognitive impairment is a transitional stage between normal cognitive aging and Alzheimer's disease or another type of dementia, and is indicative of higher risk for dementia. In addition to the obvious health and quality-of-life ramifications of dementia, there are high direct (e.g., subsidizing residential care needs) and indirect (e.g., lost productivity of family caregivers) economic costs. Implementing interventions to prevent MCI and dementia among older adults is of critical importance to health and maintained quality-of-life for millions of Americans. Recent data analyses from the Advanced Cognitive Training in Vital Elderly study (ACTIVE) indicate that a specific cognitive intervention, speed of processing training (SPT), significantly delays the incidence of cognitive impairment across 10 years. The primary contribution of the proposed research will be the determination of whether this cognitive training technique successfully delays the onset of clinically defined MCI or dementia across three years.
Age-related Cognitive Decline
Alzheimer's Disease and Related Dementias
Cognitive Training
Computerized Cognitive Stimulation
PHASE3
Preventing Alzheimer's Disease with Cognitive Training: The PACT Trial The primary objective in the R56 phase was to establish the feasibility of the proposed field trial including meeting participant enrollment goals. The feasibility of the field trial was established by accruing 1000 enrolled participants. The secondary objective in the R56 phase was to ascertain participants' willingness to enroll in a longitudinal clinical trial and to subsequently complete a multispecialty clinical diagnostic evaluation, psychometric testing, MRI, PET scan, and genetic testing. Participants' willingness to allow access to medicare records was also determined. The trial is being expanded in the R01 phase with the goal of enrolling 7600 participants. The primary goal is to ascertain the effectiveness of cognitive speed of processing training (SPT) to reduce the incidence of Mild Cognitive Impairment (MCI) or dementia. Design and Outcomes: A randomized clinical trial among 7600 adults 65 years of age and older will be completed in order to test the effectiveness of computerized cognitive speed of processing training (SPT) to reduce incidence of MCI or dementia. Participants will be screened with an inclusion/exclusion questionnaire and those potentially eligible will complete brief memory screening, depression screening, and other questionnaires. Those eligible will be randomized to one of two conditions of brain games and will complete at least two in-person, supervised training sessions. Additional exercises will be completed at-home over the next 3 to 5 months followed by booster sessions 1- and 2-years later. Participants are asked to initially complete 25 sessions of training and will be asked complete an additional 10 sessions of booster training 1- and 2- years later. Participants are instructed to complete 2-3 sessions of training per week until 25 sessions are completed. At 1- year and again at 2-years, participants will be instructed to complete an additional 10 sessions of training. Sample Size and Population: Adults 65 years of age and older (N=7600) will be randomly assigned to SPT (n=3800) or the active comparator condition (n=3800).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 7600 participants |
| Masking : | TRIPLE |
| Primary Purpose : | PREVENTION |
| Official Title : | Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults |
| Actual Study Start Date : | 2019-02-19 |
| Estimated Primary Completion Date : | 2026-01-31 |
| Estimated Study Completion Date : | 2026-01-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
ACTIVE NOT RECRUITING
University of Florida
Gainesville, Florida, United States, 32611
ACTIVE NOT RECRUITING
University of Florida
Jacksonville, Florida, United States, 32209
TERMINATED
University of North Florida
Jacksonville, Florida, United States, 32224
RECRUITING
The Roskamp Institute
Sarasota, Florida, United States, 34243
RECRUITING
University of South Florida
Tampa, Florida, United States, 33620
RECRUITING
Duke Health
Durham, North Carolina, United States, 27705
RECRUITING
Clemson University Institute for Engaged Aging
Seneca, South Carolina, United States, 29672