Triage Survey for Neurology Research Eligibility (TRIAGE-Neuro)

October 23, 2023 updated by: Adams Clinical
TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials. Secondary objectives include identifying participant characteristics among the clinical trial-seeking population, identifying the percentage of potential participants currently taking prescribed memory medications that could exclude them from clinical trial participation, examining how changes in prescription memory medications impact performance on cognitive assessments, and identifying the percentage of potential participants whose laboratory results could exclude them from clinical trial participation.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Not yet recruiting
        • Copley Clinical
        • Contact:
        • Principal Investigator:
          • Dyanna Domilici, MD
      • Watertown, Massachusetts, United States, 02472
        • Recruiting
        • Adams Clinical
        • Contact:
        • Principal Investigator:
          • Sarah J Starling, PhD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Berman Clinical
        • Principal Investigator:
          • Mark Rapp, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants are primarily recruited through social media marketing and referrals from physicians.

Description

Inclusion Criteria:

  • Participant and study partner (when applicable) have signed an ICF prior to study-specific procedures being performed.
  • Participant and study partner (when applicable) are at least 18 years old.

Exclusion Criteria:

  • Participant lacks the language skills or cognitive ability to understand the screening process.
  • Participant is pregnant, breast-feeding, or planning to become pregnant.
  • History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
  • Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on Columbia-Suicide Severity Rating Scale questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
  • Moderate or severe substance use disorder within 90 days prior to screening, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
  • Any condition that in the investigator's opinion makes a participant unsuitable for the study.
  • Currently employed by Adams Clinical or a first-degree relative of an employee working on this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of the clinical trial seeking population for whom industry-sponsored clinical research is clinically appropriate, as defined as those who go on to screen for a study.
Time Frame: Up to 52 weeks
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.
Time Frame: Up to 52 weeks
Up to 52 weeks
Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications.
Time Frame: Up to 52 weeks
Change in performance on the Mini Mental Status exam. This clinician administered cognitive assessment is measured on a scale of 0-30, with higher scores indicating better memory.
Up to 52 weeks
Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications.
Time Frame: Up to 52 weeks
Change in score on the Neuropsychiatric Inventory Questionnaire. This caregiver report includes measures of both severity of neuropsychiatric symptoms (from 0-36) and caregiver distress (0-60). Higher scores indicate greater severity of symptoms and higher levels of caregiver distress.
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adams Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Estimated)

June 2, 2027

Study Completion (Estimated)

June 2, 2027

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIAGE-Neuro-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Survey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe