The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design

Abstract Comprehensive treatment of Alzheimer's disease (AD) requires not only pharmacologic treatment but also management of existing medical conditions and lifestyle modifications including diet, cognitive training, and exercise. We present the design and methodology for the Coaching for Cogn...

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Main Authors: Jared C. Roach, Junko Hara, Deborah Fridman, Jennifer C. Lovejoy, Kathleen Jade, Laura Heim, Rachel Romansik, Adrienne Swietlikowski, Sheree Phillips, Molly K. Rapozo, Maria A. Shay, Dan Fischer, Cory Funk, Lauren Dill, Michael Brant‐Zawadzki, Leroy Hood, William R. Shankle
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:Alzheimer’s & Dementia: Translational Research & Clinical Interventions
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Online Access:https://doi.org/10.1002/trc2.12318
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author Jared C. Roach
Junko Hara
Deborah Fridman
Jennifer C. Lovejoy
Kathleen Jade
Laura Heim
Rachel Romansik
Adrienne Swietlikowski
Sheree Phillips
Molly K. Rapozo
Maria A. Shay
Dan Fischer
Cory Funk
Lauren Dill
Michael Brant‐Zawadzki
Leroy Hood
William R. Shankle
author_facet Jared C. Roach
Junko Hara
Deborah Fridman
Jennifer C. Lovejoy
Kathleen Jade
Laura Heim
Rachel Romansik
Adrienne Swietlikowski
Sheree Phillips
Molly K. Rapozo
Maria A. Shay
Dan Fischer
Cory Funk
Lauren Dill
Michael Brant‐Zawadzki
Leroy Hood
William R. Shankle
author_sort Jared C. Roach
collection DOAJ
description Abstract Comprehensive treatment of Alzheimer's disease (AD) requires not only pharmacologic treatment but also management of existing medical conditions and lifestyle modifications including diet, cognitive training, and exercise. We present the design and methodology for the Coaching for Cognition in Alzheimer's (COCOA) trial. AD and other dementias result from the interplay of multiple interacting dysfunctional biological systems. Monotherapies have had limited success. More interventional studies are needed to test the effectiveness of multimodal multi‐domain therapies for dementia prevention and treatment. Multimodal therapies use multiple interventions to address multiple systemic causes and potentiators of cognitive decline and functional loss; they can be personalized, as different sets of etiologies and systems responsive to therapy may be present in different individuals. COCOA is designed to test the hypothesis that coached multimodal interventions beneficially alter the trajectory of cognitive decline for individuals on the spectrum of AD and related dementias (ADRD). COCOA is a two‐arm prospective randomized controlled trial (RCT). COCOA collects psychometric, clinical, lifestyle, genomic, proteomic, metabolomic, and microbiome data at multiple timepoints across 2 years for each participant. These data enable systems biology analyses. One arm receives standard of care and generic healthy aging recommendations. The other arm receives standard of care and personalized data‐driven remote coaching. The primary outcome measure is the Memory Performance Index (MPI), a measure of cognition. The MPI is a summary statistic of the MCI Screen (MCIS). Secondary outcome measures include the Functional Assessment Staging Test (FAST), a measure of function. COCOA began enrollment in January 2018. We hypothesize that multimodal interventions will ameliorate cognitive decline and that data‐driven health coaching will increase compliance, assist in personalizing multimodal interventions, and improve outcomes for patients, particularly for those in the early stages of the AD spectrum. Highlights The Coaching for Cognition in Alzheimer's (COCOA) trial tests personalized multimodal lifestyle interventions for Alzheimer's disease and related dementias. Dense longitudinal molecular data will be useful for future studies. Increased use of Hill's criteria in analyses may advance knowledge generation. Remote coaching may be an effective intervention. Because lifestyle interventions are inexpensive, they may be particularly valuable in reducing global socioeconomic disparities in dementia care.
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series Alzheimer’s & Dementia: Translational Research & Clinical Interventions
spelling doaj-art-c2f1c2178e654f9a8d620b6d823b6ff52025-08-20T02:38:27ZengWileyAlzheimer’s & Dementia: Translational Research & Clinical Interventions2352-87372022-01-0181n/an/a10.1002/trc2.12318The Coaching for Cognition in Alzheimer's (COCOA) trial: Study designJared C. Roach0Junko Hara1Deborah Fridman2Jennifer C. Lovejoy3Kathleen Jade4Laura Heim5Rachel Romansik6Adrienne Swietlikowski7Sheree Phillips8Molly K. Rapozo9Maria A. Shay10Dan Fischer11Cory Funk12Lauren Dill13Michael Brant‐Zawadzki14Leroy Hood15William R. Shankle16Institute for Systems Biology Seattle Washington USAPickup Family Neurosciences Institute Hoag Memorial Hospital Presbyterian Newport Beach California USAHoag Center for Research and Education Hoag Memorial Hospital Presbyterian Newport Beach California USAInstitute for Systems Biology Seattle Washington USAInstitute for Systems Biology Seattle Washington USAHoag Center for Research and Education Hoag Memorial Hospital Presbyterian Newport Beach California USAHoag Center for Research and Education Hoag Memorial Hospital Presbyterian Newport Beach California USAHoag Center for Research and Education Hoag Memorial Hospital Presbyterian Newport Beach California USAHoag Center for Research and Education Hoag Memorial Hospital Presbyterian Newport Beach California USAProvidence St. Joseph Health Renton Washington USAInstitute for Systems Biology Seattle Washington USAInstitute for Systems Biology Seattle Washington USAInstitute for Systems Biology Seattle Washington USAPickup Family Neurosciences Institute Hoag Memorial Hospital Presbyterian Newport Beach California USAPickup Family Neurosciences Institute Hoag Memorial Hospital Presbyterian Newport Beach California USAInstitute for Systems Biology Seattle Washington USAPickup Family Neurosciences Institute Hoag Memorial Hospital Presbyterian Newport Beach California USAAbstract Comprehensive treatment of Alzheimer's disease (AD) requires not only pharmacologic treatment but also management of existing medical conditions and lifestyle modifications including diet, cognitive training, and exercise. We present the design and methodology for the Coaching for Cognition in Alzheimer's (COCOA) trial. AD and other dementias result from the interplay of multiple interacting dysfunctional biological systems. Monotherapies have had limited success. More interventional studies are needed to test the effectiveness of multimodal multi‐domain therapies for dementia prevention and treatment. Multimodal therapies use multiple interventions to address multiple systemic causes and potentiators of cognitive decline and functional loss; they can be personalized, as different sets of etiologies and systems responsive to therapy may be present in different individuals. COCOA is designed to test the hypothesis that coached multimodal interventions beneficially alter the trajectory of cognitive decline for individuals on the spectrum of AD and related dementias (ADRD). COCOA is a two‐arm prospective randomized controlled trial (RCT). COCOA collects psychometric, clinical, lifestyle, genomic, proteomic, metabolomic, and microbiome data at multiple timepoints across 2 years for each participant. These data enable systems biology analyses. One arm receives standard of care and generic healthy aging recommendations. The other arm receives standard of care and personalized data‐driven remote coaching. The primary outcome measure is the Memory Performance Index (MPI), a measure of cognition. The MPI is a summary statistic of the MCI Screen (MCIS). Secondary outcome measures include the Functional Assessment Staging Test (FAST), a measure of function. COCOA began enrollment in January 2018. We hypothesize that multimodal interventions will ameliorate cognitive decline and that data‐driven health coaching will increase compliance, assist in personalizing multimodal interventions, and improve outcomes for patients, particularly for those in the early stages of the AD spectrum. Highlights The Coaching for Cognition in Alzheimer's (COCOA) trial tests personalized multimodal lifestyle interventions for Alzheimer's disease and related dementias. Dense longitudinal molecular data will be useful for future studies. Increased use of Hill's criteria in analyses may advance knowledge generation. Remote coaching may be an effective intervention. Because lifestyle interventions are inexpensive, they may be particularly valuable in reducing global socioeconomic disparities in dementia care.https://doi.org/10.1002/trc2.12318Alzheimer's diseaseAlzheimer's disease and related disorderscognitive declinecognitive impairmentcognitive trainingdementia
spellingShingle Jared C. Roach
Junko Hara
Deborah Fridman
Jennifer C. Lovejoy
Kathleen Jade
Laura Heim
Rachel Romansik
Adrienne Swietlikowski
Sheree Phillips
Molly K. Rapozo
Maria A. Shay
Dan Fischer
Cory Funk
Lauren Dill
Michael Brant‐Zawadzki
Leroy Hood
William R. Shankle
The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design
Alzheimer’s & Dementia: Translational Research & Clinical Interventions
Alzheimer's disease
Alzheimer's disease and related disorders
cognitive decline
cognitive impairment
cognitive training
dementia
title The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design
title_full The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design
title_fullStr The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design
title_full_unstemmed The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design
title_short The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design
title_sort coaching for cognition in alzheimer s cocoa trial study design
topic Alzheimer's disease
Alzheimer's disease and related disorders
cognitive decline
cognitive impairment
cognitive training
dementia
url https://doi.org/10.1002/trc2.12318
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