DAC: Davos Alzheimer's Collaborative Study: Sequential Administration of Digital Testing To Screen For Cognitive Impairment Followed By Blood Based Biomarkers To Assist With Timely Detection And Accurate Diagnosis Of Alzheimer's Disease

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05379348
Collaborator
Davos Alzheimer's Collaborative (Other)
16,000
1
11.6
1383.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate how we can detect Alzheimer's disease early by using an online memory test and a simple blood test. These new methods for early diagnosis could allow people to begin treatment sooner, with the potential to improve the lives of millions of people.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
16000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Davos Alzheimer's Collaborative Study: Sequential Administration of Digital Testing To Screen For Cognitive Impairment Followed By Blood Based Biomarkers To Assist With Timely Detection And Accurate Diagnosis Of Alzheimer's Disease
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
General study participants (patients)

Other: Cognitive Assessment
Montreal Cognitive Assessment - MoCA, which is a cognitive screening tool that assesses: memory, concentration, language, and orientation to time and place. this written cognitive test should take no more than 20 minutes.
Other Names:
  • MoCA
  • Healthcare Practitioners

    Pre-Program Chart Audits (100 patients what will be chart audited)

    Outcome Measures

    Primary Outcome Measures

    1. Quantify the proportion of individuals at least 65 years old with cognitive impairment [Less than 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    Subjects must meet the following criteria for entry into the study:
    1. Male or female > 65 years of age at the time of consent;

    2. Understand and voluntarily sign an informed consent form;

    Inclusion criteria is assessed at both e-consent (assessed by participant's self-reporting of age and understanding) and in-person consent at TRI (assessed by clinical research coordinators in TRI).

    Exclusion Criteria

    Subjects who meet any of the following criteria will not be eligible for entry into the study:

    1. Subjects who are unable to hear and see well enough to complete the assessments;

    2. Prior diagnosis of dementia or Alzheimer's disease documented in their medical record and/or as diagnosed by a physician; Exclusion criteria is assessed by by participant's self-reporting of understanding and not having a prior diagnosis of dementia at the time of e-consentand visit 1 at TRI. ).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AdventHealth Translational Research Institute Orlando Florida United States 32804

    Sponsors and Collaborators

    • AdventHealth Translational Research Institute
    • Davos Alzheimer's Collaborative

    Investigators

    • Principal Investigator: Steven Smith, MD, Study PI

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AdventHealth Translational Research Institute
    ClinicalTrials.gov Identifier:
    NCT05379348
    Other Study ID Numbers:
    • 1811673
    First Posted:
    May 18, 2022
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022