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Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia (SLD3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02736695
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2016
Last Update Posted : April 8, 2022
Information provided by (Responsible Party):
Keith A. Josephs, Mayo Clinic

Brief Summary:
This study is designed to learn more about overall tau burden in the brain of patients with Primary Progressive Aphasia (PPA).

Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Drug: F-18 AV 1451 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 1, 2030
Estimated Study Completion Date : June 1, 2030

Arm Intervention/treatment
Experimental: Tau PET Scan, F-18 AV 1451
All subjects will receive a Tau PET scan.
Drug: F-18 AV 1451
Tau binding agent

Primary Outcome Measures :
  1. The investigators will be looking at the amount of Tau protein in the brain of patients with PPA. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 or language
  • Must fulfill diagnostic criteria for Primary Progressive Aphasia

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, behavioral variant frontotemporal dementia, progressive supranuclear palsy, and corticobasal syndrome will be excluded
  • Subjects who meet criteria for PPA and have mild behavioral changes, eye movement abnormalities or mild limb apraxia but who do not meet diagnostic criteria for behavioral variant frontotemporal dementia, progressive supranuclear palsy, or corticobasal syndrome respectively, will also 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).

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 identifier (NCT number): NCT02736695

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Keith A Josephs, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Keith A. Josephs, Professor of Neurology, Mayo Clinic Identifier: NCT02736695    
Other Study ID Numbers: 16-001703
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Keywords provided by Keith A. Josephs, Mayo Clinic:
Additional relevant MeSH terms:
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Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases