NCT04082611: PREVENTION

The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition

Completed NA Last updated 15 May 2025

What this trial tests

NA trial testing Data-Driven Clinical Recommendations in Alzheimer Disease in 97 participants. Completed in 10 April 2025.

Timeline

12 July 2019

Primary endpoint
10 April 2025

10 April 2025

Quick facts

Lead sponsor	Saint John's Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	97
Start date	12 July 2019
Primary completion	10 April 2025
Estimated completion	10 April 2025
Sites	1 location across United States

Drugs / interventions tested

• Data-Driven Clinical Recommendations
• Coached Data-Driven Clinical Recommendations

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

Saint John's Cancer Institute

Who can join

Adults 50 to 80, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut dysbiosis and age-related neurological diseases; an innovative approach for therapeutic interventions.
   Holmes A, Finger C, Morales-Scheihing D, Lee J, et al · · 2020 · cited 43× · PMID 32755639 · DOI 10.1016/j.trsl.2020.07.012
2. A systems-biology clinical trial of a personalized multimodal lifestyle intervention for early Alzheimer's disease.
   McEwen SC, Merrill DA, Bramen J, Porter V, et al · · 2021 · cited 14× · PMID 34295960 · DOI 10.1002/trc2.12191
3. A multi-modal medical management and lifestyle intervention increase cerebral blood flow and lowers diabetic risk in persons with early Alzheimer's disease: Mid-trial results from the PREVENTION trial.
   Bramen JE, Siddarth P, Popa ES, Kress GT, et al · · 2025 · PMID 41243261 · DOI 10.1177/13872877251388933