NCT03848312 Preventing Alzheimer's With Cognitive Training
| NCT ID | NCT03848312 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of South Florida |
| Condition | Age-related Cognitive Decline |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,600 participants |
| Start Date | 2019-02-19 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 7,600 participants in total. It began in 2019-02-19 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03848312 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Age-related Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03848312 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 7,600 participants.
Is NCT03848312 currently recruiting?
Yes, NCT03848312 is actively recruiting participants. Contact the research team at jenobrien@usf.edu for enrollment information.
Where is the NCT03848312 trial being conducted?
This trial is being conducted at Gainesville, United States, Jacksonville, United States, Jacksonville, United States, Sarasota, United States and 3 additional locations.
Who is sponsoring the NCT03848312 clinical trial?
NCT03848312 is sponsored by University of South Florida. The trial plans to enroll 7,600 participants.