Triage Survey for Neurology Research Eligibility

NCT06104852 | Recruiting

• 1 other identifier: TRIAGE-Neuro-101
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

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.

  Up to 52 weeks

Secondary Outcomes (3)

• 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

• Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications.

  Up to 52 weeks

Interventions

Survey OTHER

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 OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are primarily recruited through social media marketing and referrals from physicians.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adams Clinical: lead

Study Sites (3)

Copley Clinical

Boston, Massachusetts, 02116, United States

NOT YET RECRUITING

Adams Clinical

Watertown, Massachusetts, 02472, United States

RECRUITING

Berman Clinical

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Sarah J Starling, PhD

CONTACT

6177448542; sstarling@adamsclinical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: June 2, 2023
• Primary Completion (Estimated): June 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (3)