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TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are primarily recruited through social media marketing and referrals from physicians.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah J Starling, PhD | Contact | 6177448542 | sstarling@adamsclinical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copley Clinical | Not yet recruiting | Boston | Massachusetts | 02116 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Up to 52 weeks |
| 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 |
| Adams Clinical | Recruiting | Watertown | Massachusetts | 02472 | United States |
|
| Berman Clinical | Recruiting | New York | New York | 10029 | United States |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |