Brief Title
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
Official Title
18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers
Brief Summary
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive
supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
Condition
Progressive Supranuclear Palsy
Intervention
Flortaucipir F18
Study Arms / Comparison Groups
PSP Subjects
Description: Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
August 12, 2014
Completion Date
July 11, 2016
Primary Completion Date
July 11, 2016
Eligibility Criteria
Inclusion Criteria:
Cognitively Healthy Volunteers
- Mini-mental state examination (MMSE) ≥ 28
- No history of cognitive decline or parkinsonian motor disorder
CBD and PSP subjects
- Able to walk 10 steps with minimal assistance
- MMSE ≥ 14 and ≤ 30
- Subject has a reliable study partner who agrees to accompany subject to visits and
spends at least 5 hours per week with the subject
PSP subjects only
- Meet National Institute of Neurological Disorders and Stroke - Society for Progressive
Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the
Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial
CBD subjects only
- Meets 2013 consensus criteria for possible or probable corticobasal degeneration,
corticobasal syndrome (CBS) subtype
Exclusion Criteria:
All subjects
- Have evidence of structural abnormalities such as vascular disease, large strokes or
severe white matter disease or other mass lesion on screening MRI
- Claustrophobia
- Current clinically significant cardiovascular disease or clinically significant
abnormalities on screening electrocardiogram (e.g. corrected QT interval >450 msec)
- Have a history of risk factors for Torsades de Pointes (e.g. heart failure,
hypokalemia, family history of long QT syndrome)
- Have a current clinically significant infectious disease, endocrine or metabolic
disease, pulmonary, renal or hepatic impairment, or cancer
- Females of childbearing potential who are not surgically sterile, not refraining from
sexual activity or not using reliable methods of contraception
- Have received or participated in a trial with investigational medications in the past
30 days
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within
7 days prior to the study imaging session
- Have a history of neuroleptic use for a prolonged period of time or within the past 6
months
PSP and CBD subjects
- Have evidence of amyloid deposition
- Meet National Institute on Aging-Alzheimer's Association criteria for probable
Alzheimer's Disease
- Have any other neurological condition other than CBS or PSP that could account for
cognitive or motor deficits
- Serum or plasma progranulin level less than one standard deviation below the normal
subject mean for the laboratory performing the assay
- Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43
pathology or known mutations
Gender
All
Ages
50 Years - 85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02167594
Organization ID
18F-AV-1451-A09
Responsible Party
Sponsor
Study Sponsor
Avid Radiopharmaceuticals
Study Sponsor
Medical Director, Study Director, Avid Radiopharmaceuticals, Inc.
Verification Date
August 2020