Clinical trial NCT06104852: Triage Survey for Neurology Research Eligibility
Official title: Triage Survey for Neurology Research Eligibility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Adams Clinical
Sponsor class: NETWORK
First posted: 2023-10-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are primarily recruited through social media marketing and referrals from physicians.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.
timeFrame: Up to 52 weeks
measure: Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications.
timeFrame: Up to 52 weeks
measure: Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications.
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: New York
country: United States
facility: Berman Clinical
state: New York
Study officials:
References: