Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Saint John's Cancer Institute.
NCT04082611 is a NA study that has completed, run by Saint John's Cancer Institute. The registered enrollment target is 97 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To test the hypothesis that high contact coaching is better than no coaching for people in the early stages and at risk for cognitive decline. We plan to test that after one year of coached data-driven personalized interventions, participants in the coaching (CDDCR) (Group 2) will have less cognitive decline than the non-coaching (DDCR) arm (Group 1) as measured by the NIH ToolBox Cognition Function Battery (NIHTB-CB). The Cognitive Function Composite Score will be our primary outcome measure f
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 |
What the finished NCT04082611 record still lists
NCT04082611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Data-Driven Clinical Recommendations is the first listed.
NCT04082611 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04082611's enrollment target sits among peer trials
97 923rd of 2000 higher than 1,076 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03948490 · 97 participants · NA
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
- NCT04140487 · 97 participants · Phase 1
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
- NCT04196413 · 97 participants · Phase 1
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
- NCT05223816 · 97 participants · Phase 2
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI