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

Официальное название

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

Обзор

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.

Подробное описание

There are two types of participants in this study, HCP participants and patient participants. Outcome measures relate to the HCP management of patient participants.

Вмешательства

• Диагностический тест P-tau217
  Blood biomarker testing
• Другое Standard of Care
  Standard of care

Первичные конечные точки

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

Вторичные конечные точки (10)

• Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action [Срок оценки: 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: [Срок оценки: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group [Срок оценки: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Initiating AD Therapy Between the PCP Tested Group and the PCP Control Group [Срок оценки: 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 [Срок оценки: 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: [Срок оценки: 6 and 12 Months]
• Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 6 and 12 Months]

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• SiteRx Virtual Site — New York

Идентификаторы

NCT: NCT07140744 · 28782 · J4Y-MC-S003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗