TRIAGE-Neuro: Triage Survey for Neurology Research Eligibility

Sponsor

Adams Clinical (Other)

Overall Status

Recruiting

CT.gov ID

NCT06104852

Collaborator

(none)

600

Enrollment

Locations

Anticipated Duration (Months)

200

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Other: Survey Other: Optional Medication Washout

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Triage Survey for Neurology Research Eligibility

Actual Study Start Date :

Jun 2, 2023

Anticipated Primary Completion Date :

Jun 2, 2027

Anticipated Study Completion Date :

Jun 2, 2027

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Copley Clinical	Boston	Massachusetts	United States	02116
2	Adams Clinical	Watertown	Massachusetts	United States	02472
3	Berman Clinical	New York	New York	United States	10029

Sponsors and Collaborators

Adams Clinical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adams Clinical

ClinicalTrials.gov Identifier:

NCT06104852

Other Study ID Numbers:

TRIAGE-Neuro-101

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Oct 27, 2023