NCT03313011 The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
| NCT ID | NCT03313011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Apraxia of Speech |
| Study Type | OBSERVATIONAL |
| Enrollment | 47 participants |
| Start Date | 2017-08-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 47 participants in total. It began in 2017-08-01 with a primary completion date of 2027-07.
⚠ 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 purpose of this study is to identify and distinguish two different types of Progressive Apraxia of Speech through clinical imaging and testing.
Eligibility Criteria
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.
Contact & Investigator
Keith Josephs, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03313011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Apraxia of Speech. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03313011 currently recruiting?
Yes, NCT03313011 is actively recruiting participants. Contact the research team at boland.sarah@mayo.edu for enrollment information.
Where is the NCT03313011 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03313011 clinical trial?
NCT03313011 is sponsored by Mayo Clinic. The principal investigator is Keith Josephs, MD at Mayo Clinic. The trial plans to enroll 47 participants.