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Recruiting Phase 4 NCT01818661

NCT01818661 Longitudinal Multi-Modality Imaging in Progressive Apraxia of Speech

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Clinical Trial Summary
NCT ID NCT01818661
Status Recruiting
Phase Phase 4
Sponsor Mayo Clinic
Condition PPA
Study Type INTERVENTIONAL
Enrollment 50 participants
Start Date 2018-07-01
Primary Completion 2028-06

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
AV-1451

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 50 participants in total. It began in 2018-07-01 with a primary completion date of 2028-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The study is designed to determine the relationship between structural and functional changes in the brain on imaging and progression of speech and language, neurological and neuropsychological features in patients with neurodegenerative apraxia of speech (AOS).

Eligibility Criteria

Inclusion Criteria: * We will study subjects that fulfill clinical inclusion criteria for neurodegenerative AOS that have been seen and diagnosed at Mayo Clinic Exclusion Criteria: * Subjects with concurrent illnesses that could account for speech and language deficits, such as traumatic brain injury, strokes or developmental syndromes will be excluded. * Women that are pregnant or post-partum and breast-feeding will be excluded. All women who can become pregnant must have a pregnancy test no more than 48 hours before the PET scan. * Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy). * Subjects will also be excluded if they do not have an informant, or do not consent to research.

Contact & Investigator

Central Contact

Sarah Boland, CCRP

✉ boland.sarah@mayo.edu

📞 507-284-3863

Principal Investigator

Jennifer Whitwell, PhD

PRINCIPAL INVESTIGATOR

Mayo Clinic

Frequently Asked Questions

Who can join the NCT01818661 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying PPA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT01818661 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT01818661 currently recruiting?

Yes, NCT01818661 is actively recruiting participants. Contact the research team at boland.sarah@mayo.edu for enrollment information.

Where is the NCT01818661 trial being conducted?

This trial is being conducted at Rochester, United States.

Who is sponsoring the NCT01818661 clinical trial?

NCT01818661 is sponsored by Mayo Clinic. The principal investigator is Jennifer Whitwell, PhD at Mayo Clinic. The trial plans to enroll 50 participants.

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