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

Alzheimer Disease Clinical Trial

— AV1451 ADC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03809351
• Other study ID #: R19-006
• Status: Recruiting
• Phase: Phase 1
• Start date: July 8, 2020
• Est. completion date: July 8, 2025

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Chinara Dosse
• Phone: (205) 934-4501
• Email: cdosse[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 8, 2025
• Est. primary completion date: July 8, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years