Davos Alzheimer's Collaborative Study: Sequential Adminis... | NCT05379348

Studies
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

NCT05379348

Sponsor

AdventHealth Translational Research Institute

Status

Completed

Last Update Posted

Mar 30, 2026Actual

Enrollment

1,423Actual

Phase

Not provided

Conditions

Alzheimer Disease

Interventions

Cognitive Assessment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2022Actual

Primary Completion Date

Aug 5, 2025Actual

Completion Date

Aug 5, 2025Actual

First Submitted Date

May 13, 2022

First Submission Date that Met QC Criteria

May 17, 2022

First Posted Date

May 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Name	Class
Davos Alzheimer's Collaborative	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,423Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General study participants (patients)			Other: Cognitive Assessment
Healthcare Practitioners
Pre-Program Chart Audits (100 patients what will be chart audited)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Assessment	Other	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.

Measure	Description	Time Frame
Quantify the proportion of individuals at least 65 years old with cognitive impairment		Less than 6 months

Eligibility Module

Eligibility Criteria

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. ).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Healthy male and females ages >65 years old.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Smith, MD	Study PI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AdventHealth Translational Research Institute		Orlando	Florida	32804	United States

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities