Phase
Condition
N/ATreatment
P-tau217
Standard of Care
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Health Care Provider (HCP) Definitions
Primary care physician (PCPs): physicians such as family medicine practitioners andinternists who do not specialize in neurological care.
Secondary care physicians (SCPs): physicians such as geriatricians or neurologistswho see patients for specific reasons.
Tertiary care physicians (TCPs): specialty neurologists who focus on certainneurological 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 ina family practice or internist setting.
Group 2: SCPs and TCPs with experience diagnosing and treating patients withcognitive impairment and dementia.
Additional inclusion criteria applying to HCPs in the interventional group:
- Must be willing to review educational materials provided by the study sponsor,before enrolling patients.
Patient Participant Criteria
Participants in the interventional group are eligible to be included in the studyonly 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 durationof 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, misplacingitems, difficulty concentrating, or new challenges with problem solving.
Exclusion
Patient Participant Exclusion Criteria:
In the 18 months prior to identification have prior or associated HCP-orderedreferral 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'sopinion could interfere with completion of the study or have a life expectancy ofless than 1 year.
Has a known brain lesion, pathology, or prior alternative diagnosis that couldexplain the participant's clinical presentation.
Study Design
Study Description
Connect with a study center
SiteRx Virtual Site
New York 5128581, New York 5128638 10013
United StatesActive - Recruiting

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