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

NCT ID: NCT06011681

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Depression

Seniors diagnosed with late life depression or with a concern of late life depression.

No interventions assigned to this group

Mild cognitive impairment

Seniors with self-reported decline in cognitive function or with a diagnosis of mild cognitive impairment.

No interventions assigned to this group

Healthy controls

Seniors with no neurological or psychiatric symptoms or conditions.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Miro Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shenly Glenn, BS

Role: PRINCIPAL_INVESTIGATOR

Miro Health

Locations

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Miro Health

Sacramento, California, United States

Site Status RECRUITING

Miro Health

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shenly Glenn

Role: CONTACT

415-300-0533

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

Role: CONTACT

5 1 0 - 2 9 2 - 8 0 1 7

Facility Contacts

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Shenly Glenn

Role: primary

Shenly Glenn

Role: primary

Other Identifiers

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MH202206MCILLD

Identifier Type: -

Identifier Source: org_study_id

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