Alzheimer Disease
Conditions
Brief summary
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
OTHERSurvey
Participants will be surveyed on demographics, medical history, and current memory and cognitive concerns. Vitals signs, urine drug screen, blood draw may be collected.
OTHEROptional 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.
Sponsors
Adams Clinical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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. | Up to 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of the clinical trial seeking population who enroll in industry-sponsored studies. | Up to 52 weeks | — |
| Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications. | 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. |
| Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications. | 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. |
Countries
United States
Contacts
Primary ContactSarah J Starling, PhD
Outcome results
None listed