Coaching for Cognition in Alzheimer's (COCOA)

Up to 200 FAST Stages 2-4 patients with cognitive impairment will be randomized into
data-driven health coaching vs. control groups. The participants will be treated and
monitored for 24 months.

Subject Identification and Recruitment Study participants will be recruited from a
high-volume memory clinic and a large physician medical group. Up to 200 participants will be
enrolled in this prospective randomized study (up to 100 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.

FAST staging (see Attachment II for the FAST administrating and scoring) 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 subjects: FAST stages 2-3 participants are
usually competent to make 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.

This approach has been evaluated by the Department of Psychiatry and Behavioral Sciences at
Johns Hopkins, and found to adequately ensure informed consent (Black et al. 2010). 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.

Inclusion Criteria:

- Participants must be age 50 and older (no age upper limit) at time of informed
consent.

- 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
for healthcare)

- 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

Exclusion Criteria:

- 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
cognitive impairment.

- 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.