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The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition (PREVENTION)

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ClinicalTrials.gov Identifier: NCT04082611
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
Institute for Systems Biology
St. Joseph's Healthcare Foundation
Information provided by (Responsible Party):
David Merrill, John Wayne Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 24, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE July 12, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score [ Time Frame: 1 year ]
    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.
  • RAVLT (Rey's Auditory Verbal Learning Test) score [ Time Frame: 1 year ]
    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.
  • Hippocampal Volume [ Time Frame: 1 year ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
Blood Urine Nitrogen [ Time Frame: 1 year ]
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 lower blood urea levels (BUN) than the non-coaching (DDCR) arm (Group 1) as measured by the plasma BUN. Participants will be assessed at baseline and one year.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition
Official Title  ICMJE The PREVENTION Trial: Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions to Optimize Neurocognition
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.

Detailed Description

Subject identification and recruitment - All participants will be recruited from the Pacific Brain Health Center in Santa Monica, which is a high-volume memory-care and dementia outpatient clinic within a large physician medical group affiliated with Providence Saint John's Health Center. 60 participants will be randomized into the RCT, with 30 in each treatment arm.

Procedures for Obtaining Informed Consent - All participants will receive the Experimental Research Subject's Bill of Rights prior to signing the informed consent form (ICF), authorization of use and disclosure of protected health information (PHI), and authorization of medical record release for the subject's treating physician, will be obtained from each participants prior to enrolling in the study. A copy of all signed ICF's will be given to the participants, and the investigator will retain the original.

A Functional Assessment Staging Test (FAST) will be done before participants are consented to determine whether they or a legally appointed representative (LAR) can consent to participate in the study. In this study, participants with FAST stages 2-4 will be recruited (see Inclusion Criteria).

Considerations for consenting: FAST Stages 2-3 Participants - FAST stages 2-3 participants are usually capable of making medical and legal decisions, and will be consented directly, unless there is a caregiver, legally appointed representative, or other reason to think that an informed consent cannot be given by the participants without approval by a reliable informant acting on their behalf.

Considerations for consenting: FAST Stage 4 (mild dementia) Participants - FAST stage 4 participants will be consented by having them give oral or written assent, indicating their preference with regard to study participation. In addition, the caregiver or legally appointed representative of a demented participants will be consented to assure full understanding of study procedures and willingness on behalf of the participants to participate in the study.

The consenting approach for patients with cognitive impairment has been evaluated by the Department of Psychiatry and Behavioral Sciences at Johns Hopkins, and found to adequately ensure informed consent. They concluded that ADRD participants should not be excluded from study participation if they cannot directly consent themselves, so long as their caregivers can consent, and the participants can assent, either verbally or in writing, their preference to participate in the study.

The caregiver or legally appointed representative will be required to accompany participants to participate in the required procedures. A copy of the appropriate document (e.g., the power of attorney for healthcare) will be obtained and filed with the original ICF.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
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.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Alzheimer Disease
  • Mild Cognitive Impairment
Intervention  ICMJE
  • Behavioral: Data-Driven Clinical Recommendations
    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.
  • Behavioral: Coached Data-Driven Clinical Recommendations
    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.
Study Arms  ICMJE
  • Active Comparator: Group 1 - Data-driven clinical recommendations (CR)
    Data-driven clinical recommendations (CR)
    Intervention: Behavioral: Data-Driven Clinical Recommendations
  • Experimental: Group 2 - Data-driven coached multi-modal intervention (MMIC)
    Data-driven coached multi-modal intervention (MMIC)
    Intervention: Behavioral: Coached Data-Driven Clinical Recommendations
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.

Exclusion Criteria

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Bramen, PhD 310-829-8043 jbramen@pacificneuro.org
Contact: Jared Roach, MD 2067322108 jroach@systemsbiology.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04082611
Other Study ID Numbers  ICMJE 20190583
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Merrill, John Wayne Cancer Institute
Study Sponsor  ICMJE John Wayne Cancer Institute
Collaborators  ICMJE
  • Institute for Systems Biology
  • St. Joseph's Healthcare Foundation
Investigators  ICMJE Not Provided
PRS Account John Wayne Cancer Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP