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

Primary Purpose

Alzheimer Disease

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

[F-18]AV-1451-PET

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UABRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Measurement of pathological tau deposition in the brain.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03809351

First Posted

January 14, 2019

Last Updated

July 6, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03809351

Brief Title

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

Acronym

AV1451 ADC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2020 (Actual)

Primary Completion Date

July 8, 2025 (Anticipated)

Study Completion Date

July 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

[F-18]AV-1451-PET

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of pathological tau deposition in the brain.

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chinara Dosse

Phone

(205) 934-4501

cdosse@uabmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Carol Chambless

Phone

(205) 975-9569

cchambless@uabmc.edu

Facility Information:

Facility Name

UAB

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

April Riddle

Phone

205-934-6504

ariddle@uabmc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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