DepressionNCT06011681
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
An observational study of Depression and Mild Cognitive Impairment, run by Miro Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Mild Cognitive Impairment
- How many people
- 960 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include healthy, worried well, depressed, and mild cognitively impaired seniors from multiple, disparate U.S. geographic regions.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Miro Health
Miami, Florida, 33070
Shenly Glenn
- Recruiting
Miro Health
Sacramento, California, 95816
Shenly Glenn
About this study
Official title: The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study
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
- Medical subject headings
- Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Year 1, Q3 - Year 2, Q2
Secondary outcomes (1)
Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment
Pairwise correlations greater than 0.8 and statistically significantly greater than 0.7 will be considered successful.
Measured: Year 1, Q1 - Year 2, Q2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start8 Sep 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miro Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shenly Glenn, BS, Principal investigator, Miro Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011681
- Sponsor's protocol ID
- MH202206MCILLD
- Status last verified
- Jan 2024
- First submitted
- 23 Aug 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study
- ClinicalTrials.gov ID
- NCT06011681
- Acronym / sponsor ID
- MH202206MCILLD
- Conditions
- Depression, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Miro HealthUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include healthy, worried well, depressed, and mild cognitively impaired seniors from multiple, disparate U.S. geographic regions.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure usability of Miro Health assessments (iOS and Android) for patients
Time frame: 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
Time frame: Year 1, Q3 - Year 2, Q2
Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment
1 secondary outcome
Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment
Time frame: Year 1, Q1 - Year 2, Q2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenly Glenn, BS principal investigator
Miro Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Mild Cognitive Impairment, run by Miro Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenly Glenn (415-300-0533, shenly@mirohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure usability of Miro Health assessments (iOS and Android) for patients (time frame: Year 1, Q3 - Year 2, Q2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.