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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011681
• Other study ID #: MH202206MCILLD
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Depressive Disorder
• Mild Cognitive Impairment

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