Cognitive training to prevent Alzheimer's disease
Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults
PHASE3 · University of South Florida · NCT03848312
This study is testing if brain games can help older adults aged 65 and up reduce their chances of developing Mild Cognitive Impairment or dementia.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 7600 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of South Florida (other) |
| Drugs / interventions | aducanumab, chemotherapy, radiation |
| Locations | 7 sites (Gainesville, Florida and 6 other locations) |
| Trial ID | NCT03848312 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of computerized cognitive speed of processing training (SPT) in reducing the incidence of Mild Cognitive Impairment (MCI) and dementia among older adults aged 65 and above. The study will enroll 7600 participants who will undergo screening for eligibility and be randomized into two groups to participate in brain games. Participants will complete various assessments, including memory and depression screenings, and will receive in-person training sessions. The trial seeks to establish a feasible intervention that could significantly impact cognitive health in aging populations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 65 and older who do not have Mild Cognitive Impairment or dementia.
Not a fit: Patients currently enrolled in another clinical trial or those with existing cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help delay or prevent the onset of Alzheimer's disease and related dementias in older adults.
How similar studies have performed: Previous studies, such as the ACTIVE study, have shown success with cognitive training interventions, suggesting potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be age 65 or older at time of consent * Have ability to speak and understand English or Spanish * Report adequate sensorimotor capacity to perform the computer exercises * Report adequate visual capacity to read from a computer screen at a typical viewing distance * Show adequate auditory capacity to understand conversational speech * Show adequate motor capacity to touch a computer screen or control a computer mouse. * Have no evidence of Mild Cognitive Impairment (MCI) or dementia, as assessed by the Montreal Cognitive Assessment score \>=26. * Have adequate mental health (no self-reported diagnoses of mental illness that would interfere with ability to comply with study procedures or benefit from intervention) * Wiling to complete all study activities * Ability to understand study procedures and comply with them for the length of the study Exclusion Criteria: * Currently enrolled in another randomized clinical trial, treatment trial, or another research study that assesses cognition * Previous participation in a cognitive training study * Self-reported vision, hearing, or motor difficulties that would interfere with the ability to complete the study interventions * Self-reported diagnosis of mild cognitive impairment, dementia, stroke, traumatic brain injury, brain tumor, or a neurological disorder that affects cognition or would interfere with the ability to benefit from the study intervention (e.g., Parkinson disease, multiple sclerosis), or any other unstable medical conditions that is predisposing to imminent cognitive or functional decline (e.g., congestive heart failure, chronic obstructive pulmonary disorder dependent on oxygen, or undergoing chemotherapy or radiation). * Self-reported use of medications typically prescribed for dementia such as: Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, Reminyl, aducanumab, Aduhlem. * Completion of 10 or more hours of a computerized cognitive training program in the last 5 years such as: Lumosity, Posit Science Brain Fitness, InSight, or Brain HQ, Lace, CogMed, CogniFit, Happy Neuron, Elevate, or Dakim * Severe depressive symptoms (Geriatric Depression Scale score \>=5)
Where this trial is running
Gainesville, Florida and 6 other locations
- University of Florida — Gainesville, Florida, United States (ACTIVE_NOT_RECRUITING)
- University of Florida — Jacksonville, Florida, United States (ACTIVE_NOT_RECRUITING)
- University of North Florida — Jacksonville, Florida, United States (TERMINATED)
- The Roskamp Institute — Sarasota, Florida, United States (RECRUITING)
- University of South Florida — Tampa, Florida, United States (RECRUITING)
- Duke Health — Durham, North Carolina, United States (RECRUITING)
- Clemson University Institute for Engaged Aging — Seneca, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Jennifer L O'Brien, PhD
- Email: jenobrien@usf.edu
- Phone: 727-873-4415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Age-related Cognitive Decline, Alzheimer's Disease and Related Dementias