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Detecting an MCI and Amyloid Digital Neuro Signature(DNS) Using Altoida's Multimodal Digital Biomarkers.

NCT06223438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 614

Last updated 2025-02-19

No results posted yet for this study

Summary

The purpose of this study is to establish multiple points of clinical validity for the Altoida digital biomarker assessment in individuals with a clinical diagnosis of cognitively normal (CN) and Mild Cognitive Impairment (MCI). Participants will use the Altoida app and the de-identified sensor data captured by the device will be used to train specific machine-learning algorithms to recognize early symptoms of cognitive decline, such as MCI or MCI with likelihood of amyloid pathology, as measured by digital biomarkers (T1 - Visit 1). Participants will be invited for an additional visit to evaluate test-retest reliability (T1' - Visit 2). Optionally, an updated variation of the Altoida app will be tested over the course of two additional visits to ensure optimal digital assessment delivery based on best practices in neuropsychological testing, user experience design, and data collection integrity (T2 - Visit 3 and T2' - Visit 4).

Conditions

  • Alzheimer Disease
  • MCI

Sponsors & Collaborators

  • Altoida

    lead INDUSTRY

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2024-12-15
Completion
2025-01-10

Countries

  • United States

Study Locations

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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 NCT06223438 on ClinicalTrials.gov