Cognitive ImpairmentNCT05900310
Linus Health CDS Retrospective Validation Study
An observational study of Cognitive Impairment and Motor Disorders, run by Linus Health, Inc. at 1 site in United States.
Trial summary
This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE. Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Motor Disorders, Dementia
- What is being tested?
- Core Cognitive Evaluation (CCE)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Aug 2023
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 55 and above, with or without cognitive symptoms, across all the healthcare organizations that Linus Health has been deployed in.
Who may be able to join
- Age 55 and above
- Has already completed the Linus Health CCE
Who cannot join
- Incomplete CCEs
- CCEs that are flagged as "Requires clinician review"
Trial locations and contacts
1 site in 1 country.
William I Morrow, B.S. contact
United States1 site
Linus Health, Inc.
Boston, Massachusetts, 02210
Ali Jannati, MD, PhD, 617-417-3002, ajannati@linus.health
William I Morrow, imorrow@linus.health
About this study
Official title: Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation
This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE.
Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.
- Conditions
- Cognitive Impairment, Motor Disorders, Dementia
- Being tested
- Core Cognitive Evaluation (CCE)
- Medical subject headings
- Cognitive Dysfunction, Motor Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Cognitive Evaluation (CCE)Diagnostic test
The Linus Health Core Cognitive Evaluation (CCE) is an easy-to-use but powerful tool to augment and facilitate cognitive health assessment during a patient's visit to their PCP. As a digital assessment solution, the CCE combines objective insights into cognitive ability with patient-reported insights to detect early signs of cognitive impairment and reveal specific modifiable risk factors earlier than the existing status quo assessments. The CCE is an FDA-listed Class II 510k exempt software as a medical device. The CCE has two components: The Digital Clock and Recall (DCR™) test and the Life and Health Questionnaire (LHQ).
What is being measured
The primary outcome is the main question the study is designed to answer.
Median rating of each CDS recommendation
Rating of clinical appropriateness on the scale of 1 (extremely inappropriate) to 9 (extremely appropriate) for each set of CDS recommendations generated by the Linus Health CCE.
Measured: 2-3 weeks
Secondary outcomes (1)
Intraclass correlation coefficient (ICC) of each rating
ICC of each rating of clinical appropriateness to evaluate the inter-rater variability.
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linus Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Jannati, MD, PhD, Principal investigator, Linus Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900310
- Sponsor's protocol ID
- CDSV-001
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation
- ClinicalTrials.gov ID
- NCT05900310
- Acronym / sponsor ID
- CDSV-001
- Conditions
- Cognitive Impairment, Motor Disorders, Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Linus Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 12 Jun 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.
This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE.
Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 55 and above, with or without cognitive symptoms, across all the healthcare organizations that Linus Health has been deployed in.
Key inclusion criteria (2 listed)
- Age 55 and above
- Has already completed the Linus Health CCE
Key exclusion criteria (2 listed)
- Incomplete CCEs
- CCEs that are flagged as "Requires clinician review"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Cognitive Evaluation (CCE)The Linus Health Core Cognitive Evaluation (CCE) is an easy-to-use but powerful tool to augment and facilitate cognitive health assessment during a patient's visit to their PCP. As a digital assessment solution, the CCE combines objective insights into cognitive ability with patient-reported insights to detect early signs of cognitive impairment and reveal specific modifiable risk factors earlier than the existing status quo assessments. The CCE is an FDA-listed Class II 510k exempt software as a medical device. The CCE has two components: The Digital Clock and Recall (DCR™) test and the Life and Health Questionnaire (LHQ). | Diagnostic test | – |
Primary outcome
Median rating of each CDS recommendation
Time frame: 2-3 weeks
Rating of clinical appropriateness on the scale of 1 (extremely inappropriate) to 9 (extremely appropriate) for each set of CDS recommendations generated by the Linus Health CCE.
1 secondary outcome
Intraclass correlation coefficient (ICC) of each rating
Time frame: 2-3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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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.
William I Morrow, B.S. contact
Ali Jannati, MD, PhD principal investigator
Linus Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Motor Disorders, run by Linus Health, Inc. at 1 site 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 2 inclusion and 2 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ali Jannati, MD, PhD (6174173002, ajannati@linus.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median rating of each CDS recommendation (time frame: 2-3 weeks). 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 12 Jun 2023.