Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT02167594 |
Recruitment Status :
Completed
First Posted : June 19, 2014
Results First Posted : August 28, 2020
Last Update Posted : August 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Progressive Supranuclear Palsy Corticobasal Degeneration | Drug: Flortaucipir F18 Procedure: Brain PET scan | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Actual Study Start Date : | August 12, 2014 |
Actual Primary Completion Date : | July 11, 2016 |
Actual Study Completion Date : | July 11, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: PSP Subjects
Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
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Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
Procedure: Brain PET scan positron emission tomography (PET) scan of the brain 75-105 minutes post-injection |
Experimental: CBD subjects
Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
|
Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
Procedure: Brain PET scan positron emission tomography (PET) scan of the brain 75-105 minutes post-injection |
Experimental: Healthy volunteers
Healthy volunteers receiving a flortaucipir PET scan at baseline.
|
Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
Procedure: Brain PET scan positron emission tomography (PET) scan of the brain 75-105 minutes post-injection |
- Flortaucipir Imaging in PSP, CBD and Healthy Volunteers [ Time Frame: baseline and 9 month scans ]A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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 ClinicalTrials.gov identifier (NCT number): NCT02167594
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
UCSD Movement Disorder Clinic | |
La Jolla, California, United States, 92037 | |
UCSF Neurosciences Clinical Research Unit | |
San Francisco, California, United States, 94158 | |
United States, Connecticut | |
Molecular Neuroimaging | |
New Haven, Connecticut, United States, 06510 | |
United States, Pennsylvania | |
Perelman School of Medicine | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | Medical Director | Avid Radiopharmaceuticals, Inc. |
Responsible Party: | Avid Radiopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02167594 |
Other Study ID Numbers: |
18F-AV-1451-A09 |
First Posted: | June 19, 2014 Key Record Dates |
Results First Posted: | August 28, 2020 |
Last Update Posted: | August 28, 2020 |
Last Verified: | August 2020 |
Supranuclear Palsy, Progressive Paralysis Neurologic Manifestations Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Movement Disorders Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Neurodegenerative Diseases Eye Diseases |