A Phase 2 interventional study of Flortaucipir F18 and Brain PET Scan in Alzheimer Disease, sponsored by Avid Radiopharmaceuticals. Completed at 10 sites in 2 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Avid Radiopharmaceuticals (part of Eli Lilly and Company) · Phase 2, Interventional, and Diagnostic
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Among 22 studies testing flortaucipir in Alzheimer Disease — 4 open to participants now, 4 under way, none of them phase 3. flortaucipir · Alzheimer Disease.
Among the 22 studies testing flortaucipir in Alzheimer Disease, this one is the 9th largest by enrollment, is one of 2 that started in 2017, is one of 6 in phase 2, and was the 14th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →4 of the 22 studies testing flortaucipir in Alzheimer Disease are open now, in 2 countries. Recruiting first, the newest first:
Eli Radiopharma · Sites in China
Ages 50–85 · Healthy volunteers
University of Alabama at Birmingham · Sites in United States
Ages 50+ · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 60+ · Women only · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 21–80
By country, each count listing its studies:
flortaucipir: first EMA approval 2024. What it is approved for, and how studies give it, is on its page →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 60 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 7 · Phase 3 4 · Phase 4 1
First in 2013; this study’s year is marked. 2 started in 2017.
This study's enrollment of 155 is above the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 70 across the 22 interventional studies. Of the 17 that completed or were terminated, 15 (88%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 22 have an industry lead sponsor. The 6 most frequent:
This study is registered under Avid Radiopharmaceuticals, one of the names counted as Eli Lilly and Company. Under that name alone:
Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
99 studies in Alzheimer Disease by Eli Lilly and Company: 13 open now, 19 under way, 8 of them phase 3. Of 79 finished, 61 (77%) have results posted.
Among the 99 studies in Alzheimer Disease by Eli Lilly and Company, this one is the 35th largest by enrollment of the 95 interventional ones that give a count, is one of 3 that started in 2017, is one of 23 in phase 2, and was the 67th registered.
Eli Lilly and Company’s Alzheimer Disease studies by the year they started, since 2002.
2 of the studies testing flortaucipir in Alzheimer Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07580703Eli RadiopharmaA Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy | 2026-12-31 |
| NCT02740634Mayo ClinicMolecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study | 2027-03 |
Add all 2 to your calendar (.ics) → With an account.
Among the 22 studies testing flortaucipir in Alzheimer Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eli Lilly and Company’s 99 in Alzheimer Disease:
This tab as a report to print or save as PDF → With an account.
This protocol is designed to serve as a pre-screening study for subjects who are potentially eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Flortaucipir F18 · Procedure: Brain PET Scan
370 megabecquerel (MBq) IV single-dose
Also known as: 18F-AV-1451, [F-18]T807
positron emission tomography (PET) scan of the brain
Flortaucipir Qualitative Results (Visual Reads)
Flortaucipir PET scans were rated visually by an expert reader as follows: Not consistent with an AD pattern (τAD-), Moderate AD pattern (τAD+), or Advanced AD pattern and likely to progress (τAD++). Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.
Time frame: baseline scan
Flortaucipir Quantitative Results (SUVr)
Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. Visual read categories as described for previous measure. Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.
Time frame: baseline scan
Enrollment occurred between Nov 2017 and Aug 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trial AACG (Eli Lilly and Company; TRAILBLAZER-ALZ; NCT03367403)
| Milestone | Early Symptomatic AD Subjects |
|---|---|
| Started | 155 |
| Flortaucipir pet scan | 155 |
| Completed | 152 |
| Not completed | 3 |
| Withdrew: Technical difficulties | 2 |
| Withdrew: Other | 1 |
Flortaucipir PET scans were rated visually by an expert reader as follows: Not consistent with an AD pattern (τAD-), Moderate AD pattern (τAD+), or Advanced AD pattern and likely to progress (τAD++). Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.
| Participants | Early Symptomatic AD, Eligible for AACG Study | Early Symptomatic AD, Ineligible for AACG Study | Early Symptomatic AD (Total) |
|---|---|---|---|
| τAD++, advanced AD pattern | 56 | 22 | 78 |
| τAD+, moderate AD pattern | 2 | 8 | 10 |
| τAD-, pattern not consistent with AD | 0 | 64 | 64 |
Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. Visual read categories as described for previous measure. Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.
| standardized uptake value ratio (SUVr) | Early Symptomatic AD, Eligible for AACG Study | Early Symptomatic AD, Ineligible for AACG Study | Early Symptomatic AD (Total) |
|---|---|---|---|
| SUVr all | 1.21207 ± 0.119729 | 1.48576 ± 0.316435 | 1.30537 ± 0.244527 |
| SUVr τAD++ subjects | 1.21518 ± 0.120696 | 1.65880 ± 0.143067 | 1.34031 ± 0.237395 |
| SUVr τAD+ subjects | 1.12490 ± 0.012021 | 1.00991 ± 0.023239 | 1.03291 ± 0.052789 |
Collected over 48 hours after study drug administration. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Analysis Population | 0/155 (0%) | 0/155 (0%) | 2/155 (1.3%) |
| Event | Safety Analysis Population |
|---|---|
| diarrhoeaGastrointestinal disorders | 2/155 |
| Age, Continuous(years) | Early Symptomatic AD Subjects |
|---|---|
| Mean | 74.7 ± 6.19 |
| Sex: Female, Male(Participants) | Early Symptomatic AD Subjects |
|---|---|
| Female | 76 |
| Male | 79 |
| Race (NIH/OMB)(Participants) | Early Symptomatic AD Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 137 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| MMSE(units on a scale) | Early Symptomatic AD Subjects |
|---|---|
| Mean | 24.5 ± 2.18 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Aug 2018, 9 months.
Results were first posted in Aug 2020, 1 year 11 months after primary completion. A results delay was requested in Aug 2019.
Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 9 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Flortaucipir