Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia (SLD3)
Primary Purpose
Primary Progressive Aphasia, Behavioral Variant of Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F-18 AV 1451
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Progressive Aphasia focused on measuring PPA, bvFTD, FTD
Eligibility Criteria
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).
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tau PET Scan, F-18 AV 1451
Arm Description
All subjects will receive a Tau PET scan.
Outcomes
Primary Outcome Measures
The investigators will be looking at the amount of Tau protein in the brain of patients with PPA and FTD.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02736695
Brief Title
Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia
Acronym
SLD3
Official Title
Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and FTD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 1, 2030 (Anticipated)
Study Completion Date
June 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to learn more about overall tau burden in the brain of patients with Primary Progressive Aphasia (PPA) and Frontotemporal Dementia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia, Behavioral Variant of Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant
Keywords
PPA, bvFTD, FTD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tau PET Scan, F-18 AV 1451
Arm Type
Experimental
Arm Description
All subjects will receive a Tau PET scan.
Intervention Type
Drug
Intervention Name(s)
F-18 AV 1451
Intervention Description
Tau binding agent
Primary Outcome Measure Information:
Title
The investigators will be looking at the amount of Tau protein in the brain of patients with PPA and FTD.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M Boland, CCRP
Phone
507-284-3863
Email
boland.sarah@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith A Josephs, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Boland, CCRP
Phone
507-284-3863
Email
boland.sarah@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia
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