Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers

Progressive Supranuclear Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167594
• Other study ID #: 18F-AV-1451-A09
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2014
• Est. completion date: July 11, 2016

Study information

• Verified date: August 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 11, 2016
• Est. primary completion date: July 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Corticobasal Degeneration
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)

Procedure:
• Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UCSD Movement Disorder Clinic	La Jolla	California
United States	Molecular Neuroimaging	New Haven	Connecticut
United States	Perelman School of Medicine	Philadelphia	Pennsylvania
United States	UCSF Neurosciences Clinical Research Unit	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flortaucipir Imaging in PSP, CBD and Healthy Volunteers	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.	baseline and 9 month scans