Alzheimer DiseasePREVENTIONNCT04082611
The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition
A study testing Data-Driven Clinical Recommendations and Coached Data-Driven Clinical Recommendations in people with Alzheimer Disease and Mild Cognitive Impairment, run by Saint John's Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Data-Driven Clinical Recommendations and Coached Data-Driven Clinical Recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Brain Health Center
Santa Monica, California, 90404
About this study
Official title: The PREVENTION Trial: Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions 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 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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Data-Driven Clinical Recommendations, Coached Data-Driven Clinical Recommendations
- Keywords
- Alzheimer Disease, Mild Cognitive Impairment, Precision Medicine, Health Coaching, Multi-Modal Intervention, Personal, Dense, Dynamic Data (PD3) Clouds, Cognitive decline
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-Driven Clinical RecommendationsBehavioural
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.
Coached Data-Driven Clinical RecommendationsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Group 1 - Data-driven clinical recommendations (CR) | Active comparator | Data-driven clinical recommendations (CR) Receives: Behavioral: Data-Driven Clinical Recommendations |
| Group 2 - Data-driven coached multi-modal intervention (MMIC) | Experimental | Data-driven coached multi-modal intervention (MMIC) Receives: Behavioral: Coached Data-Driven Clinical Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Blood Urine Nitrogen
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start12 Jul 2019
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Systems Biology, St. Joseph's Healthcare Foundation
- Responsible party
- Principal investigator, David Merrill, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082611
- Sponsor's protocol ID
- 20190583
- Acronym
- PREVENTION
- Status last verified
- Feb 2025
- First submitted
- 24 Jul 2019
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barnes DE, Yaffe K. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep;10(9):819-28. doi: 10.1016/S1474-4422(11)70072-2. Epub 2011 Jul 19.
PubMed 21775213Black BS, Rabins PV, Sugarman J, Karlawish JH. Seeking assent and respecting dissent in dementia research. Am J Geriatr Psychiatry. 2010 Jan;18(1):77-85. doi: 10.1097/JGP.0b013e3181bd1de2.
PubMed 20094021Friedenreich CM, Courneya KS, Bryant HE. The lifetime total physical activity questionnaire: development and reliability. Med Sci Sports Exerc. 1998 Feb;30(2):266-74. doi: 10.1097/00005768-199802000-00015.
PubMed 9502356Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
PubMed 16925881Park YH, Moon SH, Ha JY, Lee MH. The long-term effects of the health coaching self-management program for nursing-home residents. Clin Interv Aging. 2017 Jul 11;12:1079-1088. doi: 10.2147/CIA.S137821. eCollection 2017.
PubMed 28744111Jack CR Jr, Bernstein MA, Fox NC, Thompson P, Alexander G, Harvey D, Borowski B, Britson PJ, L Whitwell J, Ward C, Dale AM, Felmlee JP, Gunter JL, Hill DL, Killiany R, Schuff N, Fox-Bosetti S, Lin C, Studholme C, DeCarli CS, Krueger G, Ward HA, Metzger GJ, Scott KT, Mallozzi R, Blezek D, Levy J, Debbins JP, Fleisher AS, Albert M, Green R, Bartzokis G, Glover G, Mugler J, Weiner MW. The Alzheimer's Disease Neuroimaging Initiative (ADNI): MRI methods. J Magn Reson Imaging. 2008 Apr;27(4):685-91. doi: 10.1002/jmri.21049.
PubMed 18302232Pfeffer RI, Kurosaki TT, Harrah CH Jr, Chance JM, Filos S. Measurement of functional activities in older adults in the community. J Gerontol. 1982 May;37(3):323-9. doi: 10.1093/geronj/37.3.323.
PubMed 7069156Price ND, Magis AT, Earls JC, Glusman G, Levy R, Lausted C, McDonald DT, Kusebauch U, Moss CL, Zhou Y, Qin S, Moritz RL, Brogaard K, Omenn GS, Lovejoy JC, Hood L. A wellness study of 108 individuals using personal, dense, dynamic data clouds. Nat Biotechnol. 2017 Aug;35(8):747-756. doi: 10.1038/nbt.3870. Epub 2017 Jul 17.
PubMed 28714965Thom DH, Hessler D, Willard-Grace R, DeVore D, Prado C, Bodenheimer T, Chen EH. Health coaching by medical assistants improves patients' chronic care experience. Am J Manag Care. 2015 Oct;21(10):685-91.
PubMed 26633093Willard-Grace R, Chen EH, Hessler D, DeVore D, Prado C, Bodenheimer T, Thom DH. Health coaching by medical assistants to improve control of diabetes, hypertension, and hyperlipidemia in low-income patients: a randomized controlled trial. Ann Fam Med. 2015 Mar;13(2):130-8. doi: 10.1370/afm.1768.
PubMed 25755034Norton S, Matthews FE, Barnes DE, Yaffe K, Brayne C. Potential for primary prevention of Alzheimer's disease: an analysis of population-based data. Lancet Neurol. 2014 Aug;13(8):788-94. doi: 10.1016/S1474-4422(14)70136-X.
PubMed 25030513Slavich GM, Shields GS. Assessing Lifetime Stress Exposure Using the Stress and Adversity Inventory for Adults (Adult STRAIN): An Overview and Initial Validation. Psychosom Med. 2018 Jan;80(1):17-27. doi: 10.1097/PSY.0000000000000534.
PubMed 29016550Washburn RA, McAuley E, Katula J, Mihalko SL, Boileau RA. The physical activity scale for the elderly (PASE): evidence for validity. J Clin Epidemiol. 1999 Jul;52(7):643-51. doi: 10.1016/s0895-4356(99)00049-9.
PubMed 10391658Hansmannel F, Sillaire A, Kamboh MI, Lendon C, Pasquier F, Hannequin D, Laumet G, Mounier A, Ayral AM, DeKosky ST, Hauw JJ, Berr C, Mann D, Amouyel P, Campion D, Lambert JC. Is the urea cycle involved in Alzheimer's disease? J Alzheimers Dis. 2010;21(3):1013-21. doi: 10.3233/JAD-2010-100630.
PubMed 20693631McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
PubMed 6610841
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREVENTION Trial: Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions to Optimize Neurocognition
- ClinicalTrials.gov ID
- NCT04082611
- Acronym / sponsor ID
- PREVENTION / 20190583
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- Institute for Systems Biology, St. Joseph's Healthcare Foundation
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Data-driven clinical recommendations (CR) | Active comparator | Behavioral: Data-Driven Clinical RecommendationsData-driven clinical recommendations (CR) |
| Group 2 - Data-driven coached multi-modal intervention (MMIC) | Experimental | Behavioral: Coached Data-Driven Clinical RecommendationsData-driven coached multi-modal intervention (MMIC) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data-Driven Clinical RecommendationsData-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. | Behavioural | Group 1 - Data-driven clinical recommendations (CR) |
| Coached Data-Driven Clinical RecommendationsData-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. | Behavioural | Group 2 - Data-driven coached multi-modal intervention (MMIC) |
Primary outcome
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.
1 secondary outcome
Blood Urine Nitrogen
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 21775213Barnes DE, Yaffe K. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep;10(9):819-28. doi: 10.1016/S1474-4422(11)70072-2. Epub 2011 Jul 19.
- Background: PubMed 20094021Black BS, Rabins PV, Sugarman J, Karlawish JH. Seeking assent and respecting dissent in dementia research. Am J Geriatr Psychiatry. 2010 Jan;18(1):77-85. doi: 10.1097/JGP.0b013e3181bd1de2.
- Background: PubMed 9502356Friedenreich CM, Courneya KS, Bryant HE. The lifetime total physical activity questionnaire: development and reliability. Med Sci Sports Exerc. 1998 Feb;30(2):266-74. doi: 10.1097/00005768-199802000-00015.
- Background: PubMed 16925881Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
- Background: PubMed 28744111Park YH, Moon SH, Ha JY, Lee MH. The long-term effects of the health coaching self-management program for nursing-home residents. Clin Interv Aging. 2017 Jul 11;12:1079-1088. doi: 10.2147/CIA.S137821. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-Driven Clinical Recommendations and Coached Data-Driven Clinical Recommendations in people with Alzheimer Disease and Mild Cognitive Impairment, run by Saint John's Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082611, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.