only), to evaluate the efficacy of data-driven health coaching. ‘RC only’ will serve as the
control group. Participants will be enrolled in the trial on the basis of an existence of
objective cognitive impairment defined by the MCI Screen (MCIS) and being in one of three
functional stages as defined by the Functional Assessment Staging Test (FAST). The three FAST
stages correspond to cognitive impairment without functional impairment (FAST 2), cognitive
impairment with functional impairment without impairment in instrumental activities of daily
living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with
impaired instrumental activities of daily living (FAST 4). Study objectives include measuring
treatment related changes in cognitive and functional abilities, quality of life, and
biological or biochemical measures.
A second major study objective is to analyze longitudinal multi-omic data from individuals on
a trajectory of early-stage dementia, to discover correlations between measured variables,
and identify models of causation that can further advance knowledge and research in brain
degeneration and healthy living
– Participants must be age 50 and older (no age upper limit) at time of informed
– Adults of any gender, race or ethnicity are eligible to enroll in the study.
– Participants must have cognitive impairment as demonstrated by a Memory Performance
Index (MPI) of 50 or below, or delayed free recall score of 6 or below if MPI is
greater than 50.
– Participants must have a FAST stage of 2-4.
– Participants with FAST Stage 4 must have the caregiver or legally appointed
representative who can provide an appropriate documents (e.g., the power of attorney
– Participants 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.
– Participants with medical conditions must be stable for these conditions. Stable
control on medication is acceptable.
– Participants, 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.
– Participants must be able to converse with a coach telephonically. Telephone coaching
is part of data-driven health coaching.
– Participants 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.
– Participants must have normal visual acuity (or corrected to normal) and normal color
vision as indicated by self-report
– Participants must have adequate hearing acuity as indicated by self-report
– Participants must have adequate motor capacity to use a mobile device/iPad/computer as
indicated by self-report
– Participants with an existing diagnosis of a non-AD neurodegenerative disorder (e.g.,
Lewy Body Disease, Frontal-Temporal Disease).
– Participants with a diagnosis of cerebrovascular disease as the primary cause of
– Participants who have participated in the Arivale program or the HPWP. These employed
coaching similar to the approach that will be used in the current study.
– A previously reported AD high-risk mutation (e.g., in the PSEN or 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.
- Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663