Triage Survey for Neurology Research Eligibility
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdams Clinical
About this trial
TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants are primarily recruited through social media marketing and referrals from physicians.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Survey
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
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 weeksSecondary outcomes
1
Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.
Time frame
Up to 52 weeks2
Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications.
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.
Time frame
Up to 52 weeks3
Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications.
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.
Time frame
Up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov