UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy

Phase 1

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: [F-18]AV-1451-PET

• Registration Number: NCT03809351
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing \[C-11\]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-18
• Study Start: 2020-07-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2026-07-08
• Study Completion: 2026-07-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.
3. Negative urine or serum hCG test within 2 days of [F-18]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

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Exclusion Criteria

1. Meets any exclusion criteria for the UAB-ADC study.
2. Inability or contraindication for undergoing MRI and/or PET imaging
3. Inability to participate in the imaging studies due to severity of dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[F-18]AV-1451-PET/MRI	[F-18]AV-1451-PET	All participants in this study will undergo a tau-PET imaging using the tracer \[F-18\]AV-1451 with a simultaneous PET/MRI system. The \[F-18\]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.

Primary Outcome Measures

Name	Time	Method
Measurement of pathological tau deposition in the brain.	5 years	The amount and regional distribution of pathological tau in the brains of study participants will be measured with \[F-18\]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States