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

NCT ID: NCT02167594

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-12
• Study Completion Date: 2016-07-11

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.

Conditions

Progressive Supranuclear Palsy; Corticobasal Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSP Subjects

Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.

Group Type: EXPERIMENTAL

Flortaucipir F18

Intervention Type: DRUG

IV injection, 370 megabecquerel (MBq) (10 mCi)

Brain PET scan

Intervention Type: PROCEDURE

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

CBD subjects

Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.

Group Type: EXPERIMENTAL

Flortaucipir F18

Intervention Type: DRUG

IV injection, 370 megabecquerel (MBq) (10 mCi)

Brain PET scan

Intervention Type: PROCEDURE

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

Healthy volunteers

Healthy volunteers receiving a flortaucipir PET scan at baseline.

Group Type: EXPERIMENTAL

Flortaucipir F18

Intervention Type: DRUG

IV injection, 370 megabecquerel (MBq) (10 mCi)

Brain PET scan

Intervention Type: PROCEDURE

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

Interventions

Flortaucipir F18

IV injection, 370 megabecquerel (MBq) (10 mCi)

Intervention Type: DRUG

Brain PET scan

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

Intervention Type: PROCEDURE

Other Intervention Names

[F18]T807; 18F-AV-1451; LY3191748; Tauvid

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Avid Radiopharmaceuticals, Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

UCSD Movement Disorder Clinic

La Jolla, California, United States

UCSF Neurosciences Clinical Research Unit

San Francisco, California, United States

Molecular Neuroimaging

New Haven, Connecticut, United States

Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

18F-AV-1451-A09

Identifier Type: -

Identifier Source: org_study_id