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

NCT06011681 | Unknown DMC

• 1 other identifier: MH202206MCILLD
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment

  Year 1, Q1 - Year 2, Q2

Other Outcomes (1)

• Measure relevance of algorithms in separating depressed, MCI, and healthy control groups

  Year 1, Q1 - Year 2, Q2

Study Arms (3)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miro Health: lead

Study Sites (2)

Miro Health

Sacramento, California, 95816, United States

RECRUITING

Miro Health

Miami, Florida, 33070, United States

RECRUITING

MeSH Terms

Conditions

Depression; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Shenly Glenn, BS

  Miro Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenly Glenn

CONTACT

415-300-0533; shenly@mirohealth.com

J o e l M e f f o r d, PHD

CONTACT

5 1 0 - 2 9 2 - 8 0 1 7; j o e l @ m i r o h e a l t h . c o m

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2023
• Study Start: September 8, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

US (2)