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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06011681

Enrollment

960

Registered

2023-08-25

Start date

2023-09-08

Completion date

2024-12-31

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Mild Cognitive Impairment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Measure relevance of algorithms in separating depressed, MCI, and healthy control groups	Year 1, Q1 - Year 2, Q2	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.

Countries

United States

Contacts

Primary ContactShenly Glenn

shenly@mirohealth.com415-300-0533

Backup ContactJ o e l M e f f o r d, PHD

j o e l @ m i r o h e a l t h . c o m5 1 0 - 2 9 2 - 8 0 1 7

Outcome results