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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06011681
Other study ID # MH202206MCILLD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2023
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Miro Health
Contact Shenly Glenn
Phone 415-300-0533
Email shenly@mirohealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 960
Est. completion date December 31, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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


Locations

Country Name City State
United States Miro Health Miami Florida
United States Miro Health Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Miro Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Measure relevance of algorithms in separating depressed, MCI, and healthy control groups Measure AUROC for: MCI vs healthy control; MCI vs aMCI; MCI vs depression; aMCI vs healthy control; aMCI vs depression; depression vs healthy control; and MCI + depression vs healthy control. AUROC equal to or greater than 0.84 is considered successful. Year 1, Q1 - Year 2, Q2
Primary Measure usability of Miro Health assessments (iOS and Android) for patients 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. Year 1, Q3 - Year 2, Q2
Primary Measure acceptability of Miro Health assessments (iOS and Android) for patients Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment Year 1, Q3 - Year 2, Q2
Secondary Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment Pairwise correlations greater than 0.8 and statistically significantly greater than 0.7 will be considered successful. Year 1, Q1 - Year 2, Q2
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