Triage Survey for Neurology Research Eligibility

Alzheimer Disease Clinical Trial

— TRIAGE-Neuro  

Official title:

Triage Survey for Neurology Research Eligibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104852
• Other study ID #: TRIAGE-Neuro-101
• Status: Recruiting
• Start date: June 2, 2023
• Est. completion date: June 2, 2027

Study information

• Verified date: October 2023
• Source: Adams Clinical
• Contact: Sarah J Starling, PhD
• Phone: 6177448542
• Email: sstarling[@]adamsclinical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2, 2027
• Est. primary completion date: June 2, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Copley Clinical	Boston	Massachusetts
United States	Berman Clinical	New York	New York
United States	Adams Clinical	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Adams Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.		Up to 52 weeks
Secondary	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.	Up to 52 weeks
Secondary	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.	Up to 52 weeks