Progressive Supranuclear PalsyPhase 1NCT02167594
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Progressive Supranuclear Palsy and Corticobasal Degeneration, run by Avid Radiopharmaceuticals at 5 sites in United States.
Trial summary
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy, Corticobasal Degeneration
- What is being tested?
- Flortaucipir F18 and Brain PET scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Aug 2014to 11 Jul 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
UCSD Movement Disorder Clinic
La Jolla, California, 92037
Molecular Neuroimaging
New Haven, Connecticut, 06510
Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
UCSF Neurosciences Clinical Research Unit
San Francisco, California, 94158
About this study
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
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
- Being tested
- Flortaucipir F18, Brain PET scan
- Medical subject headings
- Supranuclear Palsy, Progressive, Corticobasal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flortaucipir F18Drug
Also called [F18]T807, 18F-AV-1451, LY3191748, Tauvid
IV injection, 370 megabecquerel (MBq) (10 mCi)
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
| Study group | Role | What they receive |
|---|---|---|
| PSP Subjects | Experimental | Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months. Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
| CBD subjects | Experimental | Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months. Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
| Healthy volunteers | Experimental | Healthy volunteers receiving a flortaucipir PET scan at baseline. Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: baseline and 9 month scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start12 Aug 2014
- Primary completion11 Jul 2016
- Study completion11 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167594
- Sponsor's protocol ID
- 18F-AV-1451-A09
- Status last verified
- Aug 2020
- First submitted
- 17 Jun 2014
- Last updated
- 28 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02167594
- Acronym / sponsor ID
- 18F-AV-1451-A09
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSP Subjects | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanAmyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months. |
| CBD subjects | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanAmyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months. |
| Healthy volunteers | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanHealthy volunteers receiving a flortaucipir PET scan at baseline. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flortaucipir F18Also: [F18]T807, 18F-AV-1451, LY3191748, TauvidIV injection, 370 megabecquerel (MBq) (10 mCi) | Drug | CBD subjects, Healthy volunteers, PSP Subjects |
| Brain PET scanpositron emission tomography (PET) scan of the brain 75-105 minutes post-injection | Procedure or surgery | CBD subjects, Healthy volunteers, PSP Subjects |
Primary outcome
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
Time frame: baseline and 9 month scans
A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Avid Radiopharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Progressive Supranuclear Palsy and Corticobasal Degeneration, run by Avid Radiopharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers (time frame: baseline and 9 month scans). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.