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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Mild Cognitive Impairment

• Study Type: Observational
• Enrollment (Estimated): 960

Contacts and Locations

• Study Contact: Name: J o e l M e f f o r d, PHD; Phone Number: 5 1 0 - 2 9 2 - 8 0 1 7; Email: j o e l @ m i r o h e a l t h . c o m
• Study Contact Backup: Name: Shenly Glenn; Phone Number: 415-300-0533; Email: shenly@mirohealth.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Recruiting
      • Miro Health
      • Contact: Shenly Glenn
  • Florida
    • Miami, Florida, United States, 33070
      • Recruiting
      • Miro Health
      • Contact: Shenly Glenn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will include healthy, worried well, depressed, and mild cognitively impaired seniors from multiple, disparate U.S. geographic regions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Depression; Seniors diagnosed with late life depression or with a concern of late life depression.
Mild cognitive impairment; Seniors with self-reported decline in cognitive function or with a diagnosis of mild cognitive impairment.
Healthy controls; Seniors with no neurological or psychiatric symptoms or conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Miro Health
• Investigators: Principal Investigator: Shenly Glenn, BS, Miro Health

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Depressive Disorder; Cognitive Dysfunction
• Other Study ID Numbers: MH202206MCILLD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No