The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition

NCT04082611 | Completed

• 1 other identifier: 20190583
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Alzheimer Disease; Mild Cognitive Impairment; Precision Medicine; Health Coaching; Multi-Modal Intervention; Personal, Dense, Dynamic Data (PD3) Clouds; Cognitive decline

Outcome Measures

Primary Outcomes (3)

• NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score

  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 for cognitive function. The NIHTB-CB contains seven computer-based instruments assessing five cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. The Composite Score is calculated using all seven subsets of the NIHTB-CB. Participants will be assessed at baseline and one year.

  1 year

• RAVLT (Rey's Auditory Verbal Learning Test) score

  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 he Rey Auditory Verbal Learning Test (RAVLT). The RAVLT is a test derived for assessing verbal learning and memory. The RAVLT will be used to evaluate the changes in memory function of participants in the two different arms. Participants will be assessed at baseline and one year. Changes in RAVLT learn and recall scores will be used to assess changes in cognitive function.

  1 year

• Hippocampal Volume

  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 hippocampal volume decline than the non-coaching (DDCR) arm (Group 1) as measured by the structural magnetic resonance imaging (MRI). Participants will be assessed at baseline and one year.

  1 year

Secondary Outcomes (1)

• Blood Urine Nitrogen

  1 year

Study Arms (2)

Group 1 - Data-driven clinical recommendations (CR)

ACTIVE COMPARATOR

Data-driven clinical recommendations (CR)

Behavioral: Data-Driven Clinical Recommendations

Group 2 - Data-driven coached multi-modal intervention (MMIC)

EXPERIMENTAL

Data-driven coached multi-modal intervention (MMIC)

Behavioral: Coached Data-Driven Clinical Recommendations

Interventions

Data-Driven Clinical Recommendations BEHAVIORAL

Data-driven clinical recommendations. Participants will receive routine care with data-driven, personalized, multi-modal clinical recommendations by a study physician based on study assessments and clinical lab values and be monitored and re-assessed for a period of 12 months.

Group 1 - Data-driven clinical recommendations (CR)

Coached Data-Driven Clinical Recommendations BEHAVIORAL

Data-driven multi-modal lifestyle intervention with coaching. Participants will receive coached routine care with data-driven, personalized, multimodal recommendations. MMIC participants will receive an intensive multi-modal intervention with health coaching, support and resources to carry out these recommendations. This additional intervention services include: 13 personal, data-driven brain health coaching sessions (with an RDN), 7 personal dietary counseling sessions (with an RDN), 33 group-based cognitive and physical exercise classes (CogFit) with a certified personal trainer and a computer-based neurocognitive program at home and be monitored and re-assessed for a period of 12 months.

Group 2 - Data-driven coached multi-modal intervention (MMIC)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 web interface. If assistance is needed, it must be readily available to them.
• Subjects must be able to converse with a coach telephonically. Video-based telephone coaching is part of data-driven health coaching.
• Subjects must have regular access to a computer and the Internet along with dedicated email address since certain aspects of the program (e.g. cognitive training) are delivered electronically.
• Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
• Subject must have adequate hearing acuity as indicated by self-report.
• Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report and confirmed by staff before they are enrolled into a treatment arm.
• Subject must be cleared by a physician to participate in a moderately intensive exercise program.

You may not qualify if:

• Subjects with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Dementia, Frontal-Temporal Dementia).
• Subjects with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.
• A previously reported AD high-risk mutation (e.g., in the Presenilin Protein (PSEN) or Amyloid Precursor Protein (APP) genes) in the participant or immediate family (children, siblings, or parents). Such patients may accumulate amyloid faster than in late onset AD, and therefore may show less pronounced benefit from intervention.
• Mini Mental State Exam (MMSE) below 20.
• Clinical Dementia Rating (CDR) global score of 2 or above.

Sponsors & Collaborators

• Saint John's Cancer Institute: lead
• Institute for Systems Biology: collaborator
• St. Joseph's Healthcare Foundation: collaborator

Study Sites (1)

Pacific Brain Health Center

Santa Monica, California, 90404, United States

Location

Related Publications (16)

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Related Links

• Jacobs, P. (Ed.). (2017). NSCA's Essentials of Training Special Populations. Human Kinetics.

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be assigned with a participant identification number (ID), so that data will not be identified by any names or personally identifiable information. This ID will be used throughout this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Translational Neurosciences & Neurotherapeutics; Director, Pacific Brain Health Center

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 9, 2019
• Study Start: July 12, 2019
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-02

Locations

US (1)