ClinicalTrials.gg
CompletedNCT03467477Updated Aug 24, 2020Results posted

Tau Screening Study in Subjects With Early Symptomatic AD

A Phase 2 interventional study of Flortaucipir F18 and Brain PET Scan in Alzheimer Disease, sponsored by Avid Radiopharmaceuticals. Completed at 9 sites in United States. 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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Phase
Phase 2
Study type
Interventional
Enrollment
161
Allocation
Not applicable
Ages
60 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 22 studies testing flortaucipir in Alzheimer Disease — 4 open to participants now, 4 under way, none of them phase 3. flortaucipir · Alzheimer Disease.

Enrollment
6th of 22
161 · median 70
Started
2018
the only one that year
Phase 2
6 of 22
none open now
Registered
15th of 22
by date
Lead sponsor
15 of 22
Avid Radiopharmaceuticals

Among the 22 studies testing flortaucipir in Alzheimer Disease, this one is the 6th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 2, and was the 15th registered.

Alzheimer Disease

3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

4 of the 22 studies testing flortaucipir in Alzheimer Disease are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

About flortaucipir

flortaucipir: first EMA approval 2024. What it is approved for, and how studies give it, is on its page →

Who these studies take

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.

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02

Study summary

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.

03

Conditions studied

  • Alzheimer Disease

Browse trials for

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Patients with gradual and progressive change in memory function reported by the patient or informant for ≥6 months
  2. Patients who have a mini-mental status exam () score between 20-28 inclusive
  3. Patients who are willing to undergo a PET scan using flortaucipir F 18
  4. Patients who give or have a legally authorized representative (LAR) available to consent at the time of enrollment
  5. A study partner who must be available if the patient enters the treatment trial

Exclusion criteria

Exclusion Criteria:

  1. Are females of who are not surgically sterile, not refraining from sexual activity or not using reliable methods of . Females of childbearing potential must not be pregnant (negative serum β-HCG [beta human chorionic gonadotropin] at screening and negative urine β-HCG prior to flortaucipir F 18 injection) or breastfeeding at screening. Females should agree to avoid becoming pregnant by refraining from sexual activity or using reliable contraceptive methods for 24 hours following administration of flortaucipir F 18 injection;
  2. Patients who lack, in the investigator's opinion, adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric testing;
  3. Have significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures);
  4. Patients with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the patient's ability to complete the study [Patients with history of schizophrenia or other chronic psychosis are excluded.];
  5. Have a current serious or unstable illness including, cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a of \<24 months;
  6. Has a history of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread;
  7. Have a past history (suspected or confirmed) of or ;
  8. Are clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the Columbia-Suicide Severity Rating Scale (C-SSRS).
  9. Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit;
  10. Have a history of multiple or severe drug allergies or severe post treatment reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis)
  11. Have known positive serologic findings for (HIV) antibodies. Local laws and regulations may apply to whether testing is required.
  12. Has previous MRI evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the patient's ability to safely participate in the study;
  13. Have any for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker;
  14. Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, , or clinical laboratory test results that could be detrimental to the patient, could compromise the study, or show evidence of other etiologies for dementia.
  15. Has hypersensitivity to flortaucipir F 18 or any of its ;
  16. Intend to use drugs known to significantly prolong the within 14 days or 5 half-lives, whichever is longer, of a scheduled screening/baseline flortaucipir F 18 PET scan, or have medical history of risk factors for torsades de pointes.
  17. Have an ECG corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec (women) at screening (as determined at the site).
  18. Have poor venous access;
  19. Contraindication to PET;
  20. Present or planned exposure to ionizing radiation that, in combination with the planned administration of study PET ligands, would result in a cumulative exposure that exceeds local recommended exposure limits;
  21. Patients that are currently enrolled in any other interventional clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  22. Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product is scientifically or medically incompatible with this study and has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed prior to screening (Participation in observational studies may be permitted upon review of the observational study protocol and approval by the sponsor).
  23. Are investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling whether biological or legally adopted;
  24. Are Lilly employees or are employees of third-party organizations (TPOs) involved in a study that requires exclusion of their employees;
  25. In the opinion of the investigator, are otherwise unsuitable for a study of this type.
  26. Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 1 months [If a patient has recently stopped an AChEI and/or memantine, he or she must have discontinued treatment at least 1 months prior].
  27. Have changes in concomitant medications that could potentially affect cognition and their dosing should be stable for at least 1 month before screening, (does not apply to medications with limited duration of use, such as antibiotics).
  28. Have received active immunization agents for the treatment of Alzheimer's Disease
  29. Have known allergies to LY3303560, related compounds, or any components of the formulation; or history of significant atopy
  30. Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone;
  31. Are receiving Immunoglobulin G therapy (also known as gamma globulin or intravenous immunoglobulin [IVIG])
Terms in these criteria, in plain language(15)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    Flortaucipir PET Scan

    Drug: Flortaucipir F18 · Procedure: Brain PET Scan

Interventions

  • 370 megabecquerel (MBq) IV single-dose

    Also known as: 18F-AV-1451, [F-18]T807, LY3191748

  • ProcedureBrain PET Scan

    positron emission tomography (PET) scan of the brain

06

What researchers measure

Primary outcomes

  1. 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 future studies was determined from the flortaucipir PET scan according to protocol-specified criteria.

    Time frame: baseline scan

  2. 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.

    Time frame: baseline scan

07

Results

Posted Aug 24, 2020

Participant flow

Enrollment occurred between Mar 2018 and Nov 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trials being conducted by Eli Lilly and Company.

Participant flow — Overall Study
MilestoneEarly Symptomatic AD Subjects
Started161
Completed161
Not completed0

Outcome measures

PrimaryFlortaucipir 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 future studies was determined from the flortaucipir PET scan according to protocol-specified criteria.

Time frame:
baseline scan
Reported as:
Count of participants · Participants
Flortaucipir Qualitative Results (Visual Reads)
ParticipantsEarly Symptomatic AD, Eligible for Future TrialsEarly Symptomatic AD, Ineligible for Future TrialsEarly Symptomatic AD, Not EvaluableEarly Symptomatic AD (Total)
τAD++, advanced AD pattern5113165
τAD+, moderate AD pattern410014
τAD-, pattern not consistent with AD082082
PrimaryFlortaucipir 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.

Time frame:
baseline scan
Reported as:
Mean · standardized uptake value ratio (SUVr)
Flortaucipir Quantitative Results (SUVr)
standardized uptake value ratio (SUVr)Early Symptomatic AD, Eligible for Future TrialsEarly Symptomatic AD, Ineligible for Future TrialsEarly Symptomatic AD, Not EvaluableEarly Symptomatic AD (Total)
SUVr all subjects1.24766 ± 0.1227861.38020 ± 0.343791—1.28674 ± 0.219185
SUVr τAD++ subjects1.25687 ± 0.1225011.64935 ± 0.187100—1.33659 ± 0.209539
SUVr τAD+ subjects1.13025 ± 0.0380431.03031 ± 0.039727—1.05886 ± 0.060181

Adverse events

Collected over 48 hours after study drug administration. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Safety Analysis Population0/161 (0%)0/161 (0%)2/161 (1.2%)
Most frequent other events
Most frequent other events
EventSafety Analysis Population
claustrophobiaPsychiatric disorders2/161

Baseline characteristics

Age, Continuous
Age, Continuous(years)Early Symptomatic AD Subjects
Mean75.0 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)Early Symptomatic AD Subjects
Female93
Male68
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Early Symptomatic AD Subjects
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American4
White154
More than one race0
Unknown or Not Reported0
MMSE
MMSE(units on a scale)Early Symptomatic AD Subjects
Mean25.0 ± 2.51
08

Study locations

9 sites
  • Irvine Center for Clinical Research
    Irvine, California 92614, United States
  • Brain Matters Research
    Delray Beach, Florida 33445, United States
  • Neuropsychiatric Research Center of Southwest Florida
    Fort Myers, Florida 33912, United States
  • Renstar Medical Research
    Ocala, Florida 34470, United States
  • BioClinica Research
    Orlando, Florida 32806, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Great Lakes Clinical Trials
    Chicago, Illinois 60640, United States
  • Cotton O'neil Clinical Research Center
    Topeka, Kansas 66606, United States
  • Butler Hospital
    Providence, Rhode Island 02906, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2018, 8 months.

Results were first posted in Aug 2020, 1 year 9 months after primary completion. A results delay was requested in Nov 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 8 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.

Registered
Mar 8, 2018
First posted
Mar 16, 2018
StartActual
Mar 8, 2018
Primary completionActual
Nov 15, 2018
CompletionActual
Nov 15, 2018
Results delay requested
Nov 14, 2019
Results first posted
Aug 24, 2020
Last update
Aug 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03467477
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Mar 8, 2018
Primary completion
Nov 15, 2018
Completion
Nov 15, 2018
Results posted
Aug 24, 2020
Last update
Aug 24, 2020

Study contacts

Chief Medical Officer
study chair · Avid Radiopharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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