What side effects are associated with this type of intervention?

The context does not provide specific side effects for F-AV-1451, a tau PET imaging agent used in Primary Progressive Aphasia (PPA). However, common treatments for related dementias, such as cholinesterase inhibitors and memantine, have known side effects. Cholinesterase inhibitors can cause gastrointestinal issues, insomnia, and muscle cramps, while memantine may lead to dizziness, headache, and confusion. It is important to consult with a healthcare provider to understand the potential side effects and benefits of any treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Primary Progressive Aphasia (PPA) that target tau proteins. The F-AV-1451 trial focuses on tau PET imaging to visualize tau pathology in PPA patients, but this is a diagnostic tool rather than a treatment. Current research in Alzheimer's disease, which shares some pathological features with PPA, includes trials of anti-tau antibodies, but these have not yet led to approved treatments for PPA.

What other types of research exist?

Promising novel alternatives to F-AV-1451 for Primary Progressive Aphasia patients include newer tau PET tracers such as MK-6240 and RO-948, which have shown higher binding affinity and specificity for tau pathology. Additionally, advancements in imaging techniques like 18F-PI-2620 and 18F-GTP1 are also being explored for their potential in better visualizing tau deposits in neurodegenerative diseases.

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Tau PET Imaging for Primary Progressive Aphasia

Phase 1

Waitlist Available

Led By Emily Rogalski, Ph.D.

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a PET scan with a special tracer can map harmful protein build-up in the brains of people with language problems due to Primary Progressive Aphasia.

Who is the study for?

This trial is for individuals with Primary Progressive Aphasia and other related dementias. Participants must not be pregnant, breastfeeding, or undergoing clinical radiation treatments.

What is being tested?

The study aims to map tau protein build-up in the brain using a PET scan with a tracer called AV-1451. It will document where and how much tau protein is present in patients with Primary Progressive Aphasia.

What are the potential side effects?

While the PET scan itself is generally safe, potential side effects from the AV-1451 tracer may include allergic reactions or discomfort at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tau levels in PPA participants

Side effects data

From 2016 Phase 4 trial • 218 Patients • NCT02681172

Injection Site Pain

Injection Site Paraesthesia

Injection Site Haematoma

100%

80%

60%

40%

20%

Study treatment Arm

Safety Analysis Set

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AV-1451 RecipientsExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-AV-1451

2016

Completed Phase 2

~120

PET

2009

Completed Phase 4

~700

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Primary Progressive Aphasia (PPA) often target tau pathology, as tau proteins are involved in the formation of neurofibrillary tangles that contribute to neurodegeneration. Treatments like those studied in the F-AV-1451 trial aim to bind to tau proteins, allowing for visualization and potentially reducing or stabilizing these tangles. This is important for PPA patients because it directly addresses the underlying cause of brain degeneration, aiming to preserve language and cognitive functions for a longer period.

Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.[Antidementia Drug Therapy of Alzheimer's Dementia: Status 2018 and Outlook].Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial.