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 |
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.
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
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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