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

Conditions

• Subjective Cognitive Impairment

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• P-tau217 — DIAGNOSTIC_TEST
  Blood biomarker testing
• Standard of Care — OTHER
  Standard of care

Study Details

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.

Key Dates

Start date

Aug 22, 2025

Status verified

Oct 2025

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

7,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Other: Interventional Group
  Stratified by Primary Care Physician (PCP) versus Secondary/Tertiary Physician (S/TCP) Patient participants in the interventional group will undergo P-tau217 testing.
• Other: Standard of Care Group
  Stratified by PCP versus S/TCP Patient participants in the standard of care group (SOC) will not undergo sponsor-provided P-tau217 testing.

Primary Outcome Measure

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 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (1)

Find similar trials in New York, NY

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