The PREVENTION Trial: Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions to Optimize Neurocognition
Sponsor:
Brief Summary:
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.
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.
Locations
- Pacific Brain Health Center, Santa Monica, California, United States, 90404
