NCT04082611Completed
The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition
The PREVENTION Trial: Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions to Optimize Neurocognition
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 24 Jul 2019
- Start date
- 12 Jul 2019
- Primary completion date
- 10 Apr 2025
- Lead sponsor
- Saint John's Cancer Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT04082611
What you commit to
- Study type: Interventional
- Participants enrolled: 97
- From 12 Jul 2019 to the primary completion date, 10 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Clinical Dementia Rating (CDR) global score of 2 or above.
Other
- Mini Mental State Exam (MMSE) below 20.
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pacific Brain Health Center Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.