Alzheimer DiseaseEarly Phase 1NCT04474405
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
A Early Phase 1 study testing Flortaucipir F18, Brain PET Scan and Whole body PET scan in people with Alzheimer Disease, run by Avid Radiopharmaceuticals at 2 sites in United States.
Trial summary
This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Flortaucipir F18, Brain PET Scan and Whole body 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
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2013to 9 Dec 2013
- Phase
- Early 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
- MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
- Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)
Who cannot join
- Current clinically significant psychiatric disease.
- Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
- Claustrophobic or otherwise unable to tolerate the imaging procedure.
- Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval >450 msec).
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- History of alcohol abuse or substance abuse or dependence
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- Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
- Required medications with a narrow therapeutic window
- Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
- Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WCCT Global, LLC
Cypress, California, 90630
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
About this study
Official title: An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects
This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.
- Conditions
- Alzheimer Disease
- Being tested
- Flortaucipir F18, Brain PET Scan, Whole body PET scan, Florbetapir F 18, Brain MRI
- Medical subject headings
- Alzheimer Disease
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
IV injection, 370 MBq (10 mCi), single dose
Brain PET ScanProcedure or surgery
positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).
Whole body PET scanProcedure or surgery
positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours
Florbetapir F 18Drug
Also called Amyvid
IV injection, 370 MBq (10 mCi), single dose
Brain MRIProcedure or surgery
Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain
| Study group | Role | What they receive |
|---|---|---|
| Brain flortaucipir PET scan | Experimental | Subjects receiving a brain PET scan after flortaucipir administration Receives: Drug: Flortaucipir F18; Procedure: Brain PET Scan; Drug: Florbetapir F 18; Procedure: Brain MRI |
| Whole body flortaucipir PET scan | Experimental | Subjects receiving a whole body PET scan after flortaucipir administration Receives: Drug: Flortaucipir F18; Procedure: Whole body PET scan |
| MRI and Amyloid Extension Cohort | Other | Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355) Receives: Procedure: Brain PET Scan; Drug: Florbetapir F 18; Procedure: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Flortaucipir Uptake
Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: 80-100 minutes postdose
Flortaucipir Whole Body Effective Dose
Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model.
Measured: injection to 6 hours postdose
Secondary outcomes (3)
Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)
Spearman's correlations between flortaucipir SUVr and cognitive function as measured on the Mini-Mental State Examination (MMSE). MMSE is a 30-point questionnaire that is used to measure cognitive impairment. 0 is the lowest score and 30 is the highest score, indicating normal cognitive function. Lower MMSE scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation.
Measured: at baseline
Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)
Spearman's correlations between flortaucipir SUVr and cognitive function as measured on Digit Symbol Substitution Test (DSST). The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. Scores range from 0 to 133. Lower DSST scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation.
Measured: at baseline
Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)
Spearman's correlations between flortaucipir SUVr and cognitive function as measured on a Modified Alzheimer's Disease Assessment Scale (ADAS)-Cognitive subscale (including orientation, verbal memory, language, and praxis, minus the spoken language assessment). Scores on the modified scale can range from 0 to 65. Higher scores indicate worsening cognitive function. For this analysis, positive correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and negative correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Aug 2013
- Primary completion9 Dec 2013
- Study completion9 Dec 2013
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 Alzheimer DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT04474405
- Sponsor's protocol ID
- 18F-AV-1451-A01
- Status last verified
- Sep 2020
- First submitted
- 8 Jul 2020
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Imabayashi E, Morris A, Iaccarino L, Arora AK, Kamiki E, Lu M. 18F-flortaucipir PET imaging: Biodistribution in the Japanese population and diagnostic accuracy by Japanese readers. Ann Nucl Med. 2026 Jul 17. doi: 10.1007/s12149-026-02239-4. Online ahead of print.
PubMed 42467182
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
- An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects
- ClinicalTrials.gov ID
- NCT04474405
- Acronym / sponsor ID
- 18F-AV-1451-A01
- Conditions
- Alzheimer Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2013 (actual)
- Primary completion
- 9 Dec 2013 (actual)
- Study completion
- 9 Dec 2013 (actual)
- First posted
- 16 Jul 2020 (actual)
- 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 early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain flortaucipir PET scan | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET Scan, Drug: Florbetapir F 18, Procedure: Brain MRISubjects receiving a brain PET scan after flortaucipir administration |
| Whole body flortaucipir PET scan | Experimental | Drug: Flortaucipir F18, Procedure: Whole body PET scanSubjects receiving a whole body PET scan after flortaucipir administration |
| MRI and Amyloid Extension Cohort | Other | Procedure: Brain PET Scan, Drug: Florbetapir F 18, Procedure: Brain MRIMagnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
- MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
- Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)
Key exclusion criteria (10 listed)
- Current clinically significant psychiatric disease.
- Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
- Claustrophobic or otherwise unable to tolerate the imaging procedure.
- Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval >450 msec).
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
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, TauvidIV injection, 370 MBq (10 mCi), single dose | Drug | Brain flortaucipir PET scan, Whole body flortaucipir PET scan |
| Brain PET Scanpositron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose). | Procedure or surgery | Brain flortaucipir PET scan, MRI and Amyloid Extension Cohort |
| Whole body PET scanpositron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours | Procedure or surgery | Whole body flortaucipir PET scan |
| Florbetapir F 18Also: AmyvidIV injection, 370 MBq (10 mCi), single dose | Drug | Brain flortaucipir PET scan, MRI and Amyloid Extension Cohort |
| Brain MRIVolume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain | Procedure or surgery | Brain flortaucipir PET scan, MRI and Amyloid Extension Cohort |
Primary outcome
Brain Flortaucipir Uptake
Time frame: 80-100 minutes postdose
Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Whole Body Effective Dose
Time frame: injection to 6 hours postdose
Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model.
3 secondary outcomes
Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)
Time frame: at baseline
Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)
Time frame: at baseline
Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)
Time frame: at baseline
Results and safety
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 42467182Imabayashi E, Morris A, Iaccarino L, Arora AK, Kamiki E, Lu M. 18F-flortaucipir PET imaging: Biodistribution in the Japanese population and diagnostic accuracy by Japanese readers. Ann Nucl Med. 2026 Jul 17. doi: 10.1007/s12149-026-02239-4. Online ahead of print.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Flortaucipir F18, Brain PET Scan and Whole body PET scan in people with Alzheimer Disease, run by Avid Radiopharmaceuticals at 2 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 3 inclusion and 10 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 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Brain Flortaucipir Uptake (time frame: 80-100 minutes postdose). 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 NCT04474405, 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.