Frontotemporal DementiaPhase 1NCT03040713

Flortaucipir PET Imaging in Subjects With FTD

A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Frontotemporal Dementia, run by Avid Radiopharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Frontotemporal Dementia
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: 16 participants
Where: 3 sitesUnited States
Study dates: 11 Apr 2017to 24 Oct 2018
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
Can tolerate PET scan procedures

Who cannot join

Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
Have history of drug or alcohol dependence within the last year
Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
Have history of relevant severe drug allergy or hypersensitivity
Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session

Show all 9Show fewer

Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
Possess PET scan evidence of amyloid deposition
Determined by the investigator to be unsuitable for this type of study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

UT Southwestern Medical Center
Dallas, Texas, 75390
Movement Disorder Center, UCSD
La Jolla, California, 92037
Memory and Aging Center, UCSF
San Francisco, California, 94158

Other trials in United States

About this study

Official title: 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia

This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).

Conditions: Frontotemporal Dementia
Being tested: Flortaucipir F18, Brain PET scan
Medical subject headings: Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flortaucipir F18Drug
Also called 18F-AV-1451, [F-18]T807, LY3191748, Tauvid
370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain

Study groups in NCT03040713
Study group	Role	What they receive
FTD Subjects	Experimental	Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan 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.

Qualitative Evaluation of Flortaucipir PET Scans
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Measured: baseline scan
Quantitative Evaluation of Flortaucipir PET Scans
Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: baseline scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 201724 Oct 2018

First posted2 Feb 2017 (estimated)
Study start11 Apr 2017
Primary completion24 Oct 2018
Study completion24 Oct 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Frontotemporal DementiaStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03040713
Sponsor's protocol ID: 18F-AV-1451-A19
Status last verified: Sep 2020
First submitted: 31 Jan 2017
Last updated: 25 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Soleimani-Meigooni DN, Iaccarino L, La Joie R, Baker S, Bourakova V, Boxer AL, Edwards L, Eser R, Gorno-Tempini ML, Jagust WJ, Janabi M, Kramer JH, Lesman-Segev OH, Mellinger T, Miller BL, Pham J, Rosen HJ, Spina S, Seeley WW, Strom A, Grinberg LT, Rabinovici GD. 18F-flortaucipir PET to autopsy comparisons in Alzheimer's disease and other neurodegenerative diseases. Brain. 2020 Dec 5;143(11):3477-3494. doi: 10.1093/brain/awaa276.
PubMed 33141172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
ClinicalTrials.gov ID: NCT03040713
Acronym / sponsor ID: 18F-AV-1451-A19
Conditions: Frontotemporal Dementia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 11 Apr 2017 (actual)
Primary completion: 24 Oct 2018 (actual)
Study completion: 24 Oct 2018 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Posted 25 Sep 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 is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FTD Subjects	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanSubjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
Can tolerate PET scan procedures

Key exclusion criteria (9 listed)

Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
Have history of drug or alcohol dependence within the last year
Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
Have history of relevant severe drug allergy or hypersensitivity

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: 18F-AV-1451, [F-18]T807, LY3191748, Tauvid370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose	Drug	FTD Subjects
Brain PET scanpositron emission tomography (PET) scan of the brain	Procedure or surgery	FTD Subjects

Primary outcome

Qualitative Evaluation of Flortaucipir PET Scans
Time frame: baseline scan
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Quantitative Evaluation of Flortaucipir PET Scans
Time frame: baseline scan
Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Results and safety

Results posted to the registry on 25 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FTD Subjects	16	13

Primary outcome: Qualitative Evaluation of Flortaucipir PET Scans

Time frame: baseline scan. Count of participants. Unit: Participants

Measure	FTD Subjects n = 13
Advanced AD Scan Pattern (τAD++)	0
Moderate AD Scan Pattern (τAD+)	0
Not AD Scan Pattern (τAD-)	13

Primary outcome: Quantitative Evaluation of Flortaucipir PET Scans

Time frame: baseline scan. Mean (Standard Deviation). Unit: standardized uptake value ratio (SUVr)

Measure	FTD Subjects n = 12
MUBADA	1.00903 (0.036582)
Parietal	0.91992 (0.054753)
Temporal	0.94920 (0.041189)
Frontal	0.89825 (0.086118)
Caudate	0.63508 (0.130466)

Population analysed: All amyloid negative FTD subjects who had a PET scan that was able to be quantitatively evaluated (n=12). One subject did not have magnetic resonance imaging available, so quantitation was not possible.

Adverse events

Time frame: AEs were collected at scan visit and for 48 hours after flortaucipir administration.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FTD Subjects Safety Population	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33141172Soleimani-Meigooni DN, Iaccarino L, La Joie R, Baker S, Bourakova V, Boxer AL, Edwards L, Eser R, Gorno-Tempini ML, Jagust WJ, Janabi M, Kramer JH, Lesman-Segev OH, Mellinger T, Miller BL, Pham J, Rosen HJ, Spina S, Seeley WW, Strom A, Grinberg LT, Rabinovici GD. 18F-flortaucipir PET to autopsy comparisons in Alzheimer's disease and other neurodegenerative diseases. Brain. 2020 Dec 5;143(11):3477-3494. doi: 10.1093/brain/awaa276.

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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.

Chief Medical Officer study chair

Avid Radiopharmaceuticals

3 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 Frontotemporal Dementia, run by Avid Radiopharmaceuticals at 3 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 4 inclusion and 9 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 25 Sep 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?

Qualitative Evaluation of Flortaucipir PET Scans (time frame: baseline scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03040713, which also lists 1 linked publication.

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 25 Sep 2020.