NCT03809351

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1 alzheimer-disease

Timeline
26mo left

Started Jul 2020

Longer than P75 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2020Jul 2028

First Submitted

Initial submission to the registry

January 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

8 years

First QC Date

January 14, 2019

Last Update Submit

December 4, 2025

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

[F-18]AV-1451-PETDRUG

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.

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability or contraindication for undergoing MRI and/or PET imaging
  • Inability to participate in the imaging studies due to severity of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Chinara Dosse

CONTACT

(205) 934-4501cdosse@uabmc.edu

Carol Chambless

CONTACT

(205) 975-9569cchambless@uabmc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Molecular Imaging and Therapeutics

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 18, 2019

Study Start

July 8, 2020

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

US(1)