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NCT04082611 · ClinicalTrials.gov registry record · NA
The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition
A NA study, sponsored by Saint John's Cancer Institute.
- Completed
- Registry status
- NA
- Development phase
- 97
- Enrollment target
NCT04082611 is a NA study that has completed, run by Saint John's Cancer Institute. The registered enrollment target is 97 participants.
The verdict
NCT04082611, a NA study, has completed, sponsored by Saint John's Cancer Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 97 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Data-Driven Clinical Recommendations
- BEHAVIORAL Coached Data-Driven Clinical Recommendations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-07-12 |
| Est. Completion | 2025-04-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04082611
The ClinicalTrials.gov registry entry for NCT04082611 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Saint John's Cancer Institute, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Data-Driven Clinical Recommendations is the first listed.
NCT04082611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04082611 about?
NCT04082611 is a clinical study titled "The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition". 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 Institu...
What is the current status of trial NCT04082611?
This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2019-07-12. Estimated completion is 2025-04-10.
What interventions are being tested in trial NCT04082611?
The interventions under investigation include: Data-Driven Clinical Recommendations (BEHAVIORAL), Coached Data-Driven Clinical Recommendations (BEHAVIORAL).
Who is sponsoring clinical trial NCT04082611?
This trial is sponsored by Saint John's Cancer Institute, which has 19 total clinical trials registered on ClinicalTrials.gov.
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