Imaging of Brain Structural/Functional Connectivity and Amyloid and Tau Lesions in APOE4 Carriers.

Withdrawn

• Conditions: Alzheimer Disease
• Interventions: Drug: F 18 T807 Flortaucipir

• Registration Number: NCT03816228
• Lead Sponsor: Tammie L. S. Benzinger, MD, PhD

Brief Summary

To advance current knowledge on the vascular contributions to dementia

Detailed Description

This is a multi-center study at Washington University (WASH U), University of Southern California (USC), and Huntington Medical Research Institute (HMRI).The overall goal of both the AA program and the PPG program is to advance current knowledge on the vascular contributions to dementia particularly in individuals with the major genetic risk factor for late-onset AD, i.e., apolipoprotein E-ε4 (APOE4) gene that develop early vascular dysfunction and significant cerebrovascular pathology compared to non-carriers, and establish whether the neurovasculature plays a key role in cognitive decline, and therefore is a key new therapeutic target to treat dementia in APOE4 carriers.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Study Start: 2022-01
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female, any race
• Age > 18 years
• Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
• Normal cognition or early-stage symptomatic AD
• Females of childbearing potential without documented history of menopause or hysterectomy who do participate must not be pregnant or breastfeeding at screening
• (negative urine β-HCG within 24 hours prior to injection), and must agree to avoid becoming pregnant. Females of childbearing potential who do not agree to use reliable contraception or refrain from sexual activity for 24 hours following administration of flortaucipir injection.
• Enrollment in DCE-MRI study
• Capacity to give informed consent and follow study procedures

Exclusion Criteria

• Any illness preventing cooperation with testing or longitudinal participation
• Exclusion from the Knight ADRC or DIAN referring project
• Has a high risk for Torsades de Pointes or is taking medications known to prolong or may prolong QT interval (refer to study attachment "Restricted Medication List").
• MRI contraindications (e.g. electronic medical devices, severe claustrophobia, inability to lie still for long periods) that make it unsafe to participate in an MRI scan, using standard screening processes implemented by Washington University and Barnes-Jewish Hospital
• Currently pregnant or breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Flortaucipir	F 18 T807 Flortaucipir	Participants will receive a single intravenous bolus injection of flortaucipir along with PET imaging.

Primary Outcome Measures

Name	Time	Method
F 18 T807 Standard Uptake Value Ratios	5 years	F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States