Alzheimer DiseaseTRIAGE-NeuroNCT06104852
Triage Survey for Neurology Research Eligibility
An observational study of Alzheimer Disease, run by Adams Clinical at 3 sites in United States.
Trial summary
TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Survey and Optional Medication Washout
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jun 2023to 2 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are primarily recruited through social media marketing and referrals from physicians.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Copley Clinical
Boston, Massachusetts, 02116
Dyanna Domilici, MD, 6179345743, ddomilici@copleyclinical.com
Dyanna Domilici, MD
- Recruiting
Berman Clinical
New York, New York, 10029
Mark Rapp, MD, 9174236797, mrapp@bermanclinical.com
Mark Rapp, MD
- Recruiting
Adams Clinical
Watertown, Massachusetts, 02472
Sarah J Starling, PhD, 617-744-8542, sstarling@adamsclinical.com
Sarah J Starling, PhD
About this study
TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Survey, Optional Medication Washout
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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 WashoutOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 52 weeks
Secondary outcomes (3)
Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.
Measured: 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.
Measured: 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.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start2 Jun 2023
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adams Clinical
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104852
- Sponsor's protocol ID
- TRIAGE-Neuro-101
- Acronym
- TRIAGE-Neuro
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage Survey for Neurology Research Eligibility
- ClinicalTrials.gov ID
- NCT06104852
- Acronym / sponsor ID
- TRIAGE-Neuro / TRIAGE-Neuro-101
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Adams ClinicalResearch network
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are primarily recruited through social media marketing and referrals from physicians.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyParticipants will be surveyed on demographics, medical history, and current memory and cognitive concerns. Vitals signs, urine drug screen, blood draw may be collected. | Other | – |
| Optional Medication WashoutParticipants 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. | Other | – |
Primary outcome
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.
Time frame: Up to 52 weeks
3 secondary outcomes
Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.
Time frame: Up to 52 weeks
Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications.
Time frame: Up to 52 weeks
Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications.
Time frame: Up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Adams Clinical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah J Starling, PhD (6177448542, sstarling@adamsclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.