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New treatment option for Subjective Cognitive Impairment
Official title A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint
ClinicalTrials.gov ID: NCT07140744
What this study is testing
- What it's testing
- The purpose of the study is to measure the difference in the proportion of participants with prespecified patient management actions between a tested interventional group and a control group.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Health Care Provider (HCP) Definitions
- Primary care physician (PCPs): physicians such as family medicine practitioners and internists who do not specialize in neurological care.
- Secondary care physicians (SCPs): physicians such as geriatricians or neurologists who see patients for specific reasons.
- Tertiary care physicians (TCPs): specialty neurologists who focus on certain neurological conditions. HCP Participant Selection Criteria
- HCP inclusion criterion for each category of HCP is as follows:
You likely can't join if
- In the 18 months prior to identification have prior or associated HCP-ordered referral or prior prescription of drug therapies, for the SCIC
- Participants with previous amyloid- or tau-specific tests, defined as
- Amyloid position emission tomography (PET)
- Tau PET
- Cerebral spinal fluid (CSF) tests for amyloid beta (Aβ) and/or tau biomarkers, or
- Blood tests for Aβ and/or tau biomarkers
See the full eligibility criteria
- Health Care Provider (HCP) Definitions
- Primary care physician (PCPs): physicians such as family medicine practitioners and internists who do not specialize in neurological care.
- Secondary care physicians (SCPs): physicians such as geriatricians or neurologists who see patients for specific reasons.
- Tertiary care physicians (TCPs): specialty neurologists who focus on certain neurological conditions. HCP Participant Selection Criteria
- HCP inclusion criterion for each category of HCP is as follows:
- Group 1: PCPs who routinely evaluate and manage patients over the age of 50 in a family practice or internist setting.
- Group 2: SCPs and TCPs with experience diagnosing and treating patients with cognitive impairment and dementia. Additional applying to HCPs in the treatment group:
- Must be willing to review educational materials provided by the study sponsor, before enrolling patients. Patient Participant Criteria
- Participants in the treatment group are eligible to be included in the study only if all the following criteria apply:
- Are capable of giving, and have given, signed informed consent.
- Have venous access sufficient to allow the protocol-required blood sampling.
- Are reliable, willing, and able to make themselves available for the duration of the study and are willing to follow study procedures. Disease-specific Characteristics
- Present to the HCP with 1 or more subjective cognitive impairment complaints (SCIC) in the 4 weeks prior to identification: for example, worsening of memory, misplacing items, difficulty concentrating, or new challenges...
- In the 18 months prior to identification have prior or associated HCP-ordered referral or prior prescription of drug therapies, for the SCIC
- Participants with previous amyloid- or tau-specific tests, defined as
- Amyloid position emission tomography (PET)
- Tau PET
- Cerebral spinal fluid (CSF) tests for amyloid beta (Aβ) and/or tau biomarkers, or
- Blood tests for Aβ and/or tau biomarkers
- Has a current serious or unstable illness that in the enrolling investigator's opinion could interfere with completion of the study or have a life expectancy of less than 1 year.
- Has a known brain lesion, pathology, or prior alternative diagnosis that could explain the participant's clinical presentation.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.