Recruiting

Observational Study

Sponsor:

Miro Health

Code:

NCT06011681

Conditions

Depression

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06011681

Start date

Sep 8, 2023

Status verified date

Jan, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Nov 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

960 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Measure usability of Miro Health assessments (iOS and Android) for patients [ Time Frame: Year 1, Q3 - Year 2, Q2 ]
  • Measure acceptability of Miro Health assessments (iOS and Android) for patients [ Time Frame: Year 1, Q3 - Year 2, Q2 ]

Central Contacts and Locations

Central contacts

Shenly Glenn

415-300-0533shenly@mirohealth.com

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

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

Locations

Miro Health

Recruiting

Sacramento, California, United States, 95816

Miro Health

Recruiting

Miami, Florida, United States, 33070

More Information

Sponsor

Miro Health

Last update posted

Jan 22, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Miro Health on 2024-01-22.