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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approxiamtely 1-2 years after baseline imaging
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approxiamtely 1-2 years after baseline imaging
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approxiamtely 1-2 years after baseline imaging
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aphasia
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,961 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
330 Previous Clinical Trials
178,421 Total Patients Enrolled
4 Trials studying Apraxia of Speech
176 Patients Enrolled for Apraxia of Speech
Jennifer Whitwell, PhDPrincipal Investigator - Mayo Clinic
Mayo Clinic
2 Previous Clinical Trials
359 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like a stroke or brain injury that affects my speech.I do not have any brain conditions that could affect imaging results.I am currently pregnant or breastfeeding.I am not on any medication that could affect my brain, and I am medically stable.
Research Study Groups:
This trial has the following groups:- Group 1: Tau positron emission tomography (PET)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for participation in this research endeavor?
"According to clinicaltrials.gov, the current search for participants began on July 1st 2018 and was last modified in November of 2022 - indicating that they are still actively recruiting patients."
Answered by AI
To what extent can AV-1451 be detrimental to human health?
"AV-1451's safety has been authenticated through Phase 4 trials, so its rating is a 3 on our scale."
Answered by AI
How many individuals have volunteered for participation in this research?
"Affirmative. According to the details found on clinicaltrials.gov, this study is now enrolling patients who meet its eligibility criteria. This experiment was first listed on July 1st 2018 and last revised November 1st 2022; 50 participants are being recruited from a single location."
Answered by AI
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