NCT07140744招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action
研究概览
简要总结
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.
详细描述
There are two types of participants in this study, HCP participants and patient participants. Outcome measures relate to the HCP management of patient participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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.
研究组 & 干预措施
Interventional Group
Other
Stratified by Primary Care Physician (PCP) versus Secondary/Tertiary Physician (S/TCP)
Patient participants in the interventional group will undergo P-tau217 testing.
干预措施: P-tau217 (Diagnostic Test)
Standard of Care Group
Other
Stratified by PCP versus S/TCP
Patient participants in the standard of care group (SOC) will not undergo sponsor-provided P-tau217 testing.
干预措施: Standard of Care (Other)
结局指标
主要结局
Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action
时间窗: 6 Months
Difference in proportion of participants with a least 1 management action, referral to Secondary or Tertiary Care Physician (S/TCP); counseling; Alzheimer's Disease (AD) drug therapy related to cognitive complaint, or Non-AD drug therapy related to cognitive complaint.
次要结局
- Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group(6 and 12 Months)
- Time from Cognitive Complaint to Date of Initiating AD Therapy Between the PCP Tested Group and the PCP Control Group(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(6 and 12 Months)
- Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group(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(6 and 12 Months)
- Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action(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:(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:(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(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(6 and 12 Months)
研究者
研究点 (1)
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