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The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech (SLD4T)

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ClinicalTrials.gov Identifier: NCT03313011
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):
Keith A. Josephs, Mayo Clinic

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.

Condition or disease Intervention/treatment
Apraxia of Speech Non-fluent Aphasia Primary Progressive Aphasia Primary Progressive Nonfluent Aphasia Diagnostic Test: Testing protocol for the study

Detailed Description:
Apraxia of speech (AOS) is a motor speech disorder reflecting a problem with the programming and/or planning of speech. AOS is well recognized in the context of stroke where onset is acute and the condition improves or is stable and chronic. AOS that is insidious in onset and progresses over time because of neurodegeneration is less well recognized and understood. For the past decade the investigators have been studying patients with primary progressive apraxia of speech (PAOS). They have demonstrated that it can be the earliest manifestation of an underlying neurodegenerative disease and have recently reported that the profile of PAOS characteristics can differ among affected patients. In some instances, the speech pattern is dominated by distorted sound substitutions and additions, and other features attributable to articulatory difficulty, while in other instances the pattern is dominated by slow, prosodically segmented speech. We have designated the first profile as Phonetic PAOS (Ph-PAOS) and the second as Prosodic PAOS (Pr-PAOS; previously referred to in our studies as type 1 and 2, respectively). Importantly, it appears that the AOS pattern type may have prognostic implications. In a recent longitudinal study, the investigators observed that in some PAOS patients, the AOS remained the most salient feature over an average of seven years of the neurodegenerative disease. Other patients developed a severe extrapyramidal syndrome, resembling progressive supranuclear palsy, within five years, causing significant morbidity, including the inability to ambulate and a shortened life span; interestingly, this more aggressive course was associated with the Pr- PAOS type. At present, little is known about these types. To address the main aim to better understand the neurobiology and clinical associations of PAOS types, they will perform longitudinal speech, language, and neurocognitive testing, acoustic analyses, neuroimaging, and autopsy in a cohort of 47 new PAOS patients (for 80 PAOS patients total) and healthy controls.

Study Type : Observational
Estimated Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Group/Cohort Intervention/treatment
Progressive Apraxia of Speech Diagnostic Test: 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 Measures :
  1. Distinguish types of Progressive Apraxia of Speech [ Time Frame: 1-2 years after baseline imaging ]
    Distinguish types of PAOS using the Apraxia of Speech Rating Scale (ASRS)

Biospecimen Retention:   Samples With DNA
The investigators will be asking for an optional blood sample to be stored and used for future research.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have been diagnosed as having Progressive Apraxia of Speech.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313011

Contact: Sarah M Boland 507-284-3863 boland.sarah@mayo.edu

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah M Boland    507-284-3863    boland.sarah@mayo.edu   
Principal Investigator: Keith A Josephs, MD         
Sponsors and Collaborators
Mayo Clinic

Responsible Party: Keith A. Josephs, Consultant in Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03313011     History of Changes
Other Study ID Numbers: 17-002468
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Keith A. Josephs, Mayo Clinic:
apraxia of speech

Additional relevant MeSH terms:
Pick Disease of the Brain
Frontotemporal Dementia
Frontotemporal Lobar Degeneration
Aphasia, Primary Progressive
Aphasia, Broca
Primary Progressive Nonfluent Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychomotor Disorders
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases