Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT01818661

Conditions

PPA

Non-fluent Aphasia

Apraxia of Speech

Primary Progressive Non-fluent Aphasia

Primary Progressive Aphasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AV-1451

Study Details

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).

Conditions

PPA

Non-fluent Aphasia

Apraxia of Speech

Primary Progressive Non-fluent Aphasia

Primary Progressive Aphasia

Study ID

NCT01818661

Start date

Jul 1, 2018

Status verified date

Nov, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Tau positron emission tomography (PET)

All subjects will receive Tau PET scan on approximately day 1 or day 2 of study to assess Tau burden in the brain.

Interventions

AV-1451

This is used to assess Tau burden in the brain.

Primary outcome measure

  • measurement of longitudinal change in neuroimaging and the correlation between change on serial imaging measures and concurrent change on longitudinal measures of clinical performance in neurodegenerative AOS with or without non-fluent aphasia (NFA) [ Time Frame: approxiamtely 1-2 years after baseline imaging ]

Central Contacts and Locations

Central contacts

Sarah Boland, CCRP

507-284-3863boland.sarah@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sarah Boland, CCRP

507-284-3863boland.sarah@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • apraxia of speech
  • non-fluent aphasia
  • aphasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-12.