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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Group 1: PCPs who routinely evaluate and manage patients over the age of 50 in a family practice or internist setting.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • P-tau217

    Diagnostic test

    Blood biomarker testing

  • Standard of Care

    Other intervention

    Standard of care

Treatment groups

7,000 Participants
are divided into 2 treatment groups
Group A: Interventional GroupOther 1 intervention
Group B: Standard of Care GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Difference in Proportion of Participants Between the Primary Care Physician (PCP) Tested Group and the PCP Control Group with at Least 1 Management Action

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.

Time frame
6 Months

Secondary outcomes

1

Difference in Proportion of Participants Between the S/TCP Tested Group and the S/TCP Control Group with at Least 1 Management Action

Difference in proportion of participants with a least 1 management action, referral to S/TCP; counseling; AD drug therapy related to cognitive complaint, or Non-AD drug therapy related to cognitive complaint.

Time frame
6 and 12 Months
2

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
3

Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group

Time frame
6 and 12 Months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.