NCT05379348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

May 13, 2022

Last Update Submit

March 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantify the proportion of individuals at least 65 years old with cognitive impairment

    Less than 6 months

Study Arms (3)

General study participants (patients)

Other: Cognitive Assessment

Healthcare Practitioners

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

Interventions

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.

Also known as: MoCA
General study participants (patients)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy male and females ages \>65 years old.

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Steven Smith, MD

    Study PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

March 14, 2022

Primary Completion

August 5, 2025

Study Completion

August 5, 2025

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations