Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03313011

Conditions

Apraxia of Speech

Non-fluent Aphasia

Primary Progressive Aphasia

Primary Progressive Nonfluent Aphasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Testing protocol for the study

Study Details

Brief summary:

The purpose of this study is to identify and distinguish two different types of Progressive Apraxia of Speech through clinical imaging and testing.

Conditions

Apraxia of Speech

Non-fluent Aphasia

Primary Progressive Aphasia

Primary Progressive Nonfluent Aphasia

Study ID

NCT03313011

Start date

Aug 1, 2017

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All enrolled patients must be over the age of 18, speak English as their primary language, and have an informant who can provide an independent evaluation of functioning.
2. Each new patient must present with a chief complaint of progressive impairment of speech and must have evidence of AOS documented by a speech-language pathologist during routine clinical evaluation.
3. At study entry, all patients must have speech sufficiently intelligible for a confident diagnosis of AOS, dysarthria, and/or aphasia, and for acoustic analysis.

Exclusion Criteria:

1. Any patient whose speech is not intelligible enough for confident speech-language diagnosis will be excluded from the study.
2. All patients with concurrent illnesses that could account for speech deficits (e.g., traumatic brain injury, strokes, developmental syndromes), and patients meeting criteria for another neurodegenerative disease (e.g., Alzheimer's type dementia57), will be excluded.
3. Patients with aphasia or dysarthria who do not have PAOS, or whose aphasia or dysarthria at study entry is more severe than PAOS, will be excluded.
4. All women who are pregnant, or post-partum and breast-feeding, will be excluded as they are unable to undergo the required imaging. All women who can become pregnant must have a pregnancy test no more than 48 hours before the DaTscan.
5. Patients will also be excluded if MRI is contraindicated (e.g., metal in head, cardiac pace maker), 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).
6. Patients will be excluded if they do not have an informant, or do not consent to the research.

Study Design

Enrollment

47 participants

Anticipated

Interventions and Outcome Measures

Arms

Progressive Apraxia of Speech

Interventions

Testing protocol for the study

All patients will see a Neurologist for a neuro exam and consult, see a Speech Pathologist for assessment of speech and language skills, see the Study Coordinator for neuropsych testing (brief tests of thinking, memory, visual spatial skills, etc), undergo an MRI of the brain and a DaTscan of the brain.

Primary outcome measure

  • Distinguish types of Progressive Apraxia of Speech [ Time Frame: 1-2 years after baseline imaging ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Keith A Josephs, MD

More Information

Sponsor

Mayo Clinic

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • apraxia of speech

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 2026-05-01.