- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05379348
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 (DAC)
March 25, 2026 updated by: AdventHealth Translational Research Institute
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
1423
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Orlando, Florida, United States, 32804
- AdventHealth Translational Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy male and females ages >65 years old.
Description
Inclusion Criteria
Subjects must meet the following criteria for entry into the study:
- Male or female > 65 years of age at the time of consent;
- 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:
- Subjects who are unable to hear and see well enough to complete the assessments;
- 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. ).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General study participants (patients)
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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:
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Healthcare Practitioners
|
|
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Pre-Program Chart Audits (100 patients what will be chart audited)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quantify the proportion of individuals at least 65 years old with cognitive impairment
Time Frame: Less than 6 months
|
Less than 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Steven Smith, MD, Study PI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2022
Primary Completion (Actual)
August 5, 2025
Study Completion (Actual)
August 5, 2025
Study Registration Dates
First Submitted
May 13, 2022
First Submitted That Met QC Criteria
May 17, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 30, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1811673
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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