NCT03283449

Brief Summary

The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and to systematically document the extent and location of tau pathology in PPA patients in vivo using the same techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

9.1 years

First QC Date

May 16, 2016

Last Update Submit

April 3, 2025

Conditions

Primary Progressive Aphasia With Suspected Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Tau levels in PPA participants

    Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.

    2 years

Study Arms (1)

AV-1451 Recipients

EXPERIMENTAL

Participants in this arm of the study will all receive an injection of 10 Mci of AV-1451 and then be scanned in a PET scanner for brain imaging.

Drug: 18F-AV-1451Device: PET

Interventions

18F-AV-1451DRUG
Also known as: AV-1451
AV-1451 Recipients
PETDEVICE

PET scanner for brain imaging

AV-1451 Recipients

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have primary progressive aphasia

You may not qualify if:

  • Pregnancy
  • Breastfeeding
  • Receiving radiation clinically

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago - American School Building

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Study Officials

  • Emily Rogalski, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

September 14, 2017

Study Start

February 1, 2016

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations

US(1)