Clinical trial NCT02167594: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Progressive Supranuclear Palsy
Corticobasal Degeneration
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
timeFrame: baseline and 9 month scans
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: UCSD Movement Disorder Clinic
state: California
city: San Francisco
country: United States
facility: UCSF Neurosciences Clinical Research Unit
state: California
city: New Haven
country: United States
facility: Molecular Neuroimaging
state: Connecticut
city: Philadelphia
country: United States
facility: Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: