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



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:4/21/2016
Start Date:July 2014
End Date:June 2016

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18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers"

This study will evaluate 18F-AV-1451 for brain imaging of tau in subjects with progressive
supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.


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 probably 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 ECG (e.g. QTC>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-rsk family history suggestive of TDP-43 pathology or known mutations
We found this trial at
5
sites
San Francisco, California 94158
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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La Jolla, California 92037
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La Jolla, CA
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New Haven, Connecticut
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New Haven, CT
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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