Coaching for Cognition in Alzheimer's (COCOA)

NCT03424200 | Completed

• 1 other identifier: COCOA
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

One major study objective is, using 2 study arms (data-driven health coaching plus RC vs. RC 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

Conditions

Alzheimer Disease; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Coaching for Cognitive Decline

  Test the hypothesis that coaching is better than no coaching for people in the early stages and at risk for cognitive decline. We plan to test that after two years of coaching, participants in the coaching arm will have higher cognitive scores as measured by the MCI score. Participants in COCOA will be assessed with the MCIS, which quantifies cognition with the Memory Performance Index (MPI) component score on a 0 to 100 scale (below normal: \<50). The MPI will be our primary outcome measure for cognitive function. It is quick and inexpensive to administer. The MPI score is sensitive to slight cognitive deficits, and thus serves as an excellent single measure of cognition to serve as one of our two primary outcome measures Development and validation of the Memory Performance Index: reducing measurement error in recall tests.

  2 years

Secondary Outcomes (3)

• Diagnosis of Alzheimer's Disease

  2 years

• Memory Performance Index

  2 years

• FAST Stage

  2 years

Study Arms (2)

Coaching plus Routine Care

OTHER

Participants will receive coaching plus routine care

Other: Coaching plus routine care

Routine Care

OTHER

Participants will receive the routine care

Behavioral: Routine care

Interventions

Routine care BEHAVIORAL

Participants will receive routine care

Routine Care

Coaching plus routine care OTHER

Participants will receive coaching plus routine care

Coaching plus Routine Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead
• Institute for Systems Biology: collaborator
• Arivale: collaborator

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Leila Andres, MA

  Hoag Memorial Hospital Presbyterian

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 6, 2018
• Study Start: January 10, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

US (1)