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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02167594
• Date of registration: 17/06/2014
• Prospective Registration: Yes
• Primary sponsor: Avid Radiopharmaceuticals
• Public title: Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
• Scientific 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
• Date of first enrolment: August 12, 2014
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02167594
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Avid Radiopharmaceuticals, Inc.

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Corticobasal Degeneration

Progressive Supranuclear Palsy

Intervention(s)

Procedure: Brain PET scan

Drug: Flortaucipir F18

Primary Outcome(s)

Flortaucipir Imaging in PSP, CBD and Healthy Volunteers [Time Frame: baseline and 9 month scans]

Secondary ID(s)

18F-AV-1451-A09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02167594