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| ID | Type | Description | Link |
|---|---|---|---|
| J4Y-MC-S003 | Other Identifier | Eli Lilly and Company |
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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.
There are two types of participants in this study, HCP participants and patient participants. Outcome measures relate to the HCP management of patient participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-tau217 | Diagnostic Test | Blood biomarker testing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 Months |
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Inclusion Criteria:
Health Care Provider (HCP) Definitions
HCP Participant Selection Criteria
HCP inclusion criterion for each category of HCP is as follows:
Additional inclusion criteria applying to HCPs in the interventional group:
Patient Participant Criteria
Participants in the interventional group are eligible to be included in the study only if all the following criteria apply:
Disease-specific Characteristics
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SiteRx Virtual Site | Recruiting | New York | New York | 10013 | United States |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Standard of Care |
| Other |
Standard of care |
|
| 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 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 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 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 AD Therapy 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 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 |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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