NCT03313011

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2017Jul 2027

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

October 11, 2017

Last Update Submit

April 27, 2026

Conditions

Keywords

apraxia of speech

Outcome Measures

Primary Outcomes (1)

  • Distinguish types of Progressive Apraxia of Speech

    Distinguish types of PAOS using the Apraxia of Speech Rating Scale (ASRS)

    1-2 years after baseline imaging

Study Arms (1)

Progressive Apraxia of Speech

Diagnostic Test: Testing protocol for the study

Interventions

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.

Progressive Apraxia of Speech

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that have been diagnosed as having Progressive Apraxia of Speech.

You may qualify if:

  • 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.
  • 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.
  • At study entry, all patients must have speech sufficiently intelligible for a confident diagnosis of AOS, dysarthria, and/or aphasia, and for acoustic analysis.

You may not qualify if:

  • Any patient whose speech is not intelligible enough for confident speech-language diagnosis will be excluded from the study.
  • 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.
  • 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.
  • 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.
  • 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).
  • Patients will be excluded if they do not have an informant, or do not consent to the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will be asking for an optional blood sample to be stored and used for future research.

MeSH Terms

Conditions

ApraxiasAphasia, BrocaAphasia, Primary ProgressivePrimary Progressive Nonfluent Aphasia

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAphasiaSpeech DisordersLanguage DisordersCommunication DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Keith Josephs, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah M Boland, CCRP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Neurology

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 18, 2017

Study Start

August 1, 2017

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations