The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Depression Seniors diagnosed with late life depression or with a concern of late life depression. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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LLD: Age 60 or over; diagnosis of LLD or symptoms consonant with LLD; PHQ-9 score from 15 to 27
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MCI: Age 60 or over; diagnosis of MCI or self-reported insidious onset and continued worsening of cognitive decline; intact activities of daily living
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Miro Health
Investigators
- Principal Investigator: Shenly Glenn, BS, Miro Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MH202206MCILLD