CompletedNot Applicable

The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition

United States97 participantsStarted 2019-07-12

Plain-language summary

The PREVENTION Trial is a 12-month, two-arm randomized clinical trial (RCT) in adults 50-80 years old experiencing cognitive decline. Our study clinicians will refer patients for enrollment based on three categories: 1) a diagnosis of mild AD according to criteria established by the National Institute of Neurological and Communicative Disorders and Stroke (AD and Related Disorders Association \[NINCDS-ADRDA\]), 2) those with mild cognitive impairment will be diagnosed according to the Petersen method, and 3) subjective memory impairment as assessed by neuropsychological assessments and self-report. Enrollment will require evidence of AD pathophysiological processes (as defined by a positive amyloid positron emission tomography (PET) scan). The first objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline. Subjects will be randomized into one of two groups: Group 1 (Active Control) or Group 2 (Intervention). Group 1 (Data-driven clinical recommendations (CR)) will serve as the active control group and will receive data-driven clinical recommendations by a study physician based on study assessments and clinical lab values. Group 2 (Data-driven multi-modal intervention with coaching (MMIC)) will receive the same clinical recommendations and also an intensive multi-modal intervention with health coaching, support and resources to carry out these recommendations. This includes health coaching sessions (with an RDN), dietary counseling sessions (with an RDN), and group cognitive and physical exercise classes (CogFit) with a certified personal trainer and a computer-based neurocognitive program at home. Both groups will be measured for treatment related changes in cognitive and functional abilities, quality of life, biological, and biochemical measures. The second objective is to analyze longitudinal multi-omic data, including metabolomics, proteomics, genetics, microbiome, behavior and cognition into personalized, dense, dynamic data (i.e. PD3) from individuals with cognitive decline and underlying Alzheimer's neuropathology. The goal analysis is to identify models of causation that can further advance knowledge and research in neurodegenerative disorders and healthy living.

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Subjects must be age 50 to 80 at time of informed consent. * Subjects of any gender, race or ethnicity are eligible to enroll in the study. * Subjects must have a FAST stage of 2-4. * Subjects with FAST Stage 4 must have a caregiver or legally appointed representative willing to accompany participants to the required procedures. * As part of the study screening procedure, subjects must be willing to undergo an amyloid PET scan or have previously undergone an amyloid PET scan and agree to make the results available. Subjects must be amyloid positive to be eligible to enroll in the study. * Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study (e.g., coaching program) is currently only available in English. * Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable. Subjects should not have started any new medications for chronic conditions within the last three months. * A neurological and physical evaluation will be conducted prior to enrollment of the study by a qualified medical doctor and confirmed through medical records that they do not possess any abnormal physical or neurological sign, and/ whether they are considered to be clinically significant. Also an MMSE \>19 will be confirmed by a medical doctor prior to study enrollment. * Subjects, with or without assistance, must be able to use a computer and …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score

Timeframe: 1 year

RAVLT (Rey's Auditory Verbal Learning Test) score

Timeframe: 1 year

Hippocampal Volume

Timeframe: 1 year

Trial details

NCT IDNCT04082611

SponsorSaint John's Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-10

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.