- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02736695
Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia (SLD3)
Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and FTD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary progressive aphasia (PPA) is an umbrella term that encompasses a group of neurodegenerative syndromes characterized by varying combinations of progressive speech and language problems. Three clinical variants of PPA have been described and are well recognized: the agrammatic variant characterized by grammatical errors in speech and writing and typically associated with phonetic errors in speech; the semantic variant characterized by poor naming from loss of knowledge about the meaning of words; and the logopenic variant characterized by word retrieval problems and poor sentence repetition from impairment of working memory and phonemic errors. Pathological studies of PPA patients that died with postmortem examination of their brains have demonstrated that PPA is associated with a number of different abnormal cellular proteins that do not have perfect associations with the three PPA variants. One such protein is the microtubule associated protein, tau, which is the most common abnormal protein found in the brains of patients with PPA. Tau is an important protein that has been linked to the neurodegenerative process in many diseases. No neuroimaging studies have investigated tau deposition in PPA and hence the binding characteristics of AV-1451 (the Tau binding drug used in this study) in PPA are unknown. Understanding the binding characteristics of AV-1451 is crucial to help determine whether it can serve as a biomarker for tau deposition in the brains of patients with PPA.
FTD or Frontotemporal Dementias, including bvFTD, will also be included in this study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah M Boland, CCRP
- Phone Number: 507-284-3863
- Email: boland.sarah@mayo.edu
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Sarah Boland, CCRP
- Phone Number: 507-284-3863
- Email: boland.sarah@mayo.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be over the age of 18
- Must speak English as your primary language
- Must have an informant who can provide independent evaluation of functioning
- Must present with a chief complaint of progressive impairment of speech/language or changes in behavior
- Must fulfill diagnostic criteria for Primary Progressive Aphasia or Frontotemporal Dementia
Exclusion Criteria:
- Any subject who is mute or whose speech is unintelligible will be excluded
- All subjects with concurrent illnesses that could account for speech and language deficits, such as traumatic brain injury, strokes or developmental syndromes, and subjects meeting criteria for another neurodegenerative disease, such as amnestic Alzheimer's type dementia, dementia with Lewy bodies, progressive supranuclear palsy, and corticobasal syndrome will be excluded
- All pregnant, post-partum and breast-feeding women will be excluded
- Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc.), 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tau PET Scan, F-18 AV 1451
All subjects will receive a Tau PET scan.
|
Tau binding agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The investigators will be looking at the amount of Tau protein in the brain of patients with PPA and FTD.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith A Josephs, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Dementia
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- 16-001703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Progressive Aphasia
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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
-
University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingLogopenic Variant Primary Progressive Aphasia | Non-fluent Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive AphasiaUnited States
-
Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
-
Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
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University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
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Axon Neuroscience SEUnknownPrimary Progressive Nonfluent AphasiaGermany
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Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
-
Mayo ClinicRecruitingPrimary Progressive Aphasia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | Non-fluent AphasiaUnited States
Clinical Trials on F-18 AV 1451
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University of Alabama at BirminghamRecruitingAlzheimer DiseaseUnited States
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Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | HIVUnited States
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Tammie L. S. Benzinger, MD, PhDRecruiting
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Washington University School of MedicineEnrolling by invitationAlzheimer DiseaseUnited States
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Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | Progressive Posterior Cortical Dysfunction (PPCD)United States
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Avid RadiopharmaceuticalsWithdrawn
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Tammie L. S. Benzinger, MD, PhDWithdrawn
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Avid RadiopharmaceuticalsCompleted
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Avid RadiopharmaceuticalsCompletedAlzheimer DiseaseUnited States
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Mayo ClinicRecruitingProgressive Supranuclear PalsyUnited States