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AV-1451 Imaging for Apraxia of Speech

Phase 4
Recruiting
Led By Jennifer Whitwell, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Women that are pregnant or post-partum and breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will help researchers understand how changes in the brain affect the progression of speech and language problems in people with neurodegenerative AOS.

Who is the study for?
This trial is for individuals diagnosed with neurodegenerative apraxia of speech (AOS) at Mayo Clinic. It's not suitable for those with severe claustrophobia, pregnant or breastfeeding women, people on certain medications like chemotherapy, those with metal implants that affect MRI scans, brain structure abnormalities, or other illnesses causing speech issues.
What is being tested?
The study focuses on the drug AV-1451 to explore how changes in brain structure and function relate to the progression of AOS. Participants will undergo various imaging tests over time to track these changes and their impact on speech and language abilities.
What are the potential side effects?
While specific side effects are not detailed here, participants may experience discomfort or risks associated with imaging procedures such as PET scans and MRIs. These can include exposure to radiation (PET), loud noises during scanning (MRI), and potential reactions to contrast agents used.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tau positron emission tomography (PET)Experimental Treatment1 Intervention
All subjects will receive Tau PET scan on approximately day 1 or day 2 of study to assess Tau burden in the brain.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,299 Total Patients Enrolled
3 Trials studying Apraxia of Speech
715 Patients Enrolled for Apraxia of Speech
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
353 Previous Clinical Trials
181,427 Total Patients Enrolled
6 Trials studying Apraxia of Speech
229 Patients Enrolled for Apraxia of Speech
Jennifer Whitwell, PhDPrincipal Investigator - Mayo Clinic
Mayo Clinic
2 Previous Clinical Trials
359 Total Patients Enrolled

Media Library

AV-1451 Clinical Trial Eligibility Overview. Trial Name: NCT01818661 — Phase 4
Apraxia of Speech Research Study Groups: Tau positron emission tomography (PET)
Apraxia of Speech Clinical Trial 2023: AV-1451 Highlights & Side Effects. Trial Name: NCT01818661 — Phase 4
AV-1451 2023 Treatment Timeline for Medical Study. Trial Name: NCT01818661 — Phase 4
~18 spots leftby Jun 2028
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