Longitudinal Multi-Modality Imaging in Progressive Apraxia of Speech

NCT01818661 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 12-008988, 17-010087R01DC012519-09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

apraxia of speech; non-fluent aphasia; aphasia

Outcome Measures

Primary Outcomes (1)

• 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)

  approxiamtely 1-2 years after baseline imaging

Study Arms (1)

Tau positron emission tomography (PET)

EXPERIMENTAL

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

Drug: AV-1451

Interventions

AV-1451 DRUG

This is used to assess Tau burden in the brain.

Tau positron emission tomography (PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Aphasia, Broca; Apraxias; Primary Progressive Nonfluent Aphasia; Aphasia, Primary Progressive; Aphasia

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jennifer Whitwell, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Boland, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 26, 2013
• Study Start: July 1, 2018
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)