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NCT Number: NCT06104852

Triage Survey for Neurology Research Eligibility

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copley Clinical, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey

Other

Participants will be surveyed on demographics, medical history, and current memory and cognitive concerns. Vitals signs, urine drug screen, blood draw may be collected.

Optional Medication Washout

Other

Participants taking memory medications which require a down-taper per the judgment of the study physicians may participate in a medication washout period during study screening.

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.

    Time frame: Up to 52 weeks

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah J Starling, PhD

CONTACT

[email protected]

6177448542

Sponsors and collaborators

Lead sponsor

Adams Clinical

Network

Registry information

Acronym: TRIAGE-Neuro

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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