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Recruiting NCT06104852

Triage Survey for Neurology Research Eligibility

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survey, Optional Medication Washout.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Other Survey
    Participants will be surveyed on demographics, medical history, and current memory and cognitive concerns. Vitals signs, urine drug screen, blood draw may be collected.
  • Other Optional Medication Washout
    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 outcome measures

  • 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 outcome measures (3)
  • Proportion of the clinical trial seeking population who enroll in industry-sponsored studies. [Time frame: 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]
  • Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications. [Time frame: Up to 52 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • Copley Clinical — Boston
  • Adams Clinical — Watertown
  • Berman Clinical — New York

Identifiers

NCT: NCT06104852 · TRIAGE-Neuro-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗