Overview
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.
Description
There are two types of participants in this study, HCP participants and patient participants. Outcome measures relate to the HCP management of patient participants.
Eligibility
Inclusion 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 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 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 with problem solving.
Patient Participant Exclusion Criteria:
- 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.