A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint

Official title

A Prospective Diagnostic Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint in Primary and Secondary/Tertiary Care

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.

Detailed 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.

Interventions

• Diagnostic test P-tau217
  Blood biomarker testing
• Other Standard of Care
  Standard of care

Primary outcome measures

• Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action [Time frame: 6 Months]

Secondary outcome measures (10)

• Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Referral to a S/TCP Between the PCP Tested Group and the PCP Control Group: [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Initiating AD Therapy Between the PCP Tested Group and the PCP Control Group [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Initiating Non-AD Therapy Between the PCP Tested Group and the PCP Control Group [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Referral to a S/TCP Between the S/TCP Tested Group and the S/TCP Control Group: [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Initiating AD Therapy Between the S/TCP Tested Group and the S/TCP Control Group [Time frame: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Initiating Non-AD Therapy Between the S/TCP Tested Group and the S/TCP Control Group [Time frame: 6 and 12 Months]
• Difference in Proportion of Participants with a Documented Alzheimer's Disease-Specific International Classification of Diseases (ICD) - 10 Code Between the S/TCP Tested Group and the S/TCP Control Group [Time frame: 6 and 12 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• SiteRx Virtual Site — New York

Identifiers

NCT: NCT07140744 · 28782 · J4Y-MC-S003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗