The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over

Recruiting

• Conditions: Mild Cognitive Impairment; Depression

• Registration Number: NCT06011681
• Lead Sponsor: Miro Health

Brief Summary

Mild cognitive impairment (MCI) leading to Alzheimer's disease and related disorders (ADRD) represents a significant health and economic burden of the rapidly expanding senior population. The accurate detection and diagnosis of MCI and its common comorbidity, late-life depression (LLD), is essential for prolonging patient quality of life and developing advancements in research and treatment options. The purpose of the proposed program is to refine Miro Health's A.I. to accurately detect, differentiate and diagnose MCI and LLD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-25
• Study Start: 2023-09-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

• LLD: Age 60 or over; diagnosis of LLD or symptoms consonant with LLD; PHQ-9 score from 15 to 27
• MCI: Age 60 or over; diagnosis of MCI or self-reported insidious onset and continued worsening of cognitive decline; intact activities of daily living
• HC: Age 60 or over

Exclusion Criteria

• Age 59 or younger; history of unresolved neurological or psychiatric conditions; current medications known to affect cognition; history of substance abuse; unable to perform activities of daily living; change in employment status due to condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure usability of Miro Health assessments (iOS and Android) for patients	Year 1, Q3 - Year 2, Q2	Measure the (a) time point 1 in-assessment drop-out rate; and (b) the rate of lost-to-time-point-2-followup at 12 months.
Measure acceptability of Miro Health assessments (iOS and Android) for patients	Year 1, Q3 - Year 2, Q2	Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment

Secondary Outcome Measures

Name	Time	Method
Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment	Year 1, Q1 - Year 2, Q2	Pairwise correlations greater than 0.8 and statistically significantly greater than 0.7 will be considered successful.

Trial Locations

Locations (1)

Miro Health; 🇺🇸 Miami, Florida, United States