MedTrace Logo

Coaching for Cognition in Alzheimer's (COCOA)

NCT03424200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-09-26

No results posted yet for this study

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

Interventions

BEHAVIORAL

Routine care

Participants will receive routine care

OTHER

Coaching plus routine care

Participants will receive coaching plus routine care

Sponsors & Collaborators

  • Institute for Systems Biology

    collaborator OTHER

  • Arivale

    collaborator UNKNOWN

  • Hoag Memorial Hospital Presbyterian

    lead OTHER

Principal Investigators

  • Leila Andres, MA · Hoag Memorial Hospital Presbyterian

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03424200 on ClinicalTrials.gov