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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
7,000
Blood biomarker testing
Standard of care
SiteRx Virtual Site
New York, New York, United States
RECRUITINGDifference 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
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
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
Time from Cognitive Complaint to Date of Counseling Between the PCP Tested Group and the PCP Control Group
Time frame: 6 and 12 Months
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
Time from Cognitive Complaint to Date of Initiating Non-AD Therapy Between the PCP Tested Group and the PCP Control Group
Time frame: 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:
Time frame: 6 and 12 Months
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Time from Cognitive Complaint to Date of Counseling Between the S/TCP Tested Group and the S/TCP Control Group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 and 12 Months