AV1451 ADC: UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT03809351

Collaborator

(none)

160

Enrollment

Location

Arm

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: [F-18]AV-1451-PET	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 8, 2020

Anticipated Primary Completion Date :

Jul 8, 2025

Anticipated Study Completion Date :

Jul 8, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [F-18]AV-1451-PET/MRI 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.	Drug: [F-18]AV-1451-PET All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.

Arm

Intervention/Treatment

Experimental: [F-18]AV-1451-PET/MRI

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.

Drug: [F-18]AV-1451-PET

All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
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.
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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan E McConathy, Director, Division of Molecular Imaging and Therapeutics, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03809351

Other Study ID Numbers:

R19-006

First Posted:

Jan 18, 2019

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Jul 22, 2022