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Clinical Trials/NCT06011681
NCT06011681
Recruiting
N/A

The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study

Miro Health1 site in 1 country960 target enrollmentSeptember 8, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Miro Health
Enrollment
960
Locations
1
Primary Endpoint
Measure usability of Miro Health assessments (iOS and Android) for patients
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2023
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Miro Health
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measure usability of Miro Health assessments (iOS and Android) for patients

Time Frame: 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

Time Frame: Year 1, Q3 - Year 2, Q2

Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment

Secondary Outcomes

  • Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment(Year 1, Q1 - Year 2, Q2)

Study Sites (1)

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