Alzheimer DiseasePhase 2NCT03467477

Tau Screening Study in Subjects With Early Symptomatic AD

A Phase 2 study testing Flortaucipir F18 and Brain PET Scan in people with Alzheimer Disease, run by Avid Radiopharmaceuticals at 9 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 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. Read more about this study

Who is it for?: Ages 60 to 85 years
Conditions the study is for: Alzheimer Disease
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: 161 participants
Where: 9 sitesUnited States
Study dates: 8 Mar 2018to 15 Nov 2018
Phase: Phase 2
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 60 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. 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;
Patients who lack, in the investigator's opinion, adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric testing;
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);
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.];
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 life expectancy of <24 months;
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;

Show all 31Show fewer

Have a past history (suspected or confirmed) of Hepatitis B or Hepatitis C;
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).
Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit;
Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis)
Have known positive serologic findings for human immunodeficiency virus (HIV) antibodies. Local laws and regulations may apply to whether testing is required.
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;
Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker;
Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, ECG, or clinical laboratory test results that could be detrimental to the patient, could compromise the study, or show evidence of other etiologies for dementia.
Has hypersensitivity to flortaucipir F 18 or any of its excipients;
Intend to use drugs known to significantly prolong the QT interval 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.
Have an ECG corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec (women) at screening (as determined at the investigational site).
Have poor venous access;
Contraindication to PET;
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;
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
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).
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;
Are Lilly employees or are employees of third-party organizations (TPOs) involved in a study that requires exclusion of their employees;
In the opinion of the investigator, are otherwise unsuitable for a study of this type.
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].
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).
Have received active immunization agents for the treatment of Alzheimer's Disease
Have known allergies to LY3303560, related compounds, or any components of the formulation; or history of significant atopy
Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone;
Are receiving Immunoglobulin G therapy (also known as gamma globulin or intravenous immunoglobulin [IVIG])

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

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

Other trials in United States

About this study

Official title: A Multicenter Screening Study With Flortaucipir F 18 in Patients With Early Symptomatic AD; #2

Conditions: Alzheimer Disease
Being tested: Flortaucipir F18, Brain PET Scan
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
370 megabecquerel (MBq) IV single-dose
Brain PET ScanProcedure or surgery
positron emission tomography (PET) scan of the brain

Study groups in NCT03467477
Study group	Role	What they receive
Flortaucipir PET Scan	Experimental	Not described 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 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.
Measured: 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.
Measured: baseline scan

Timeline

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

8 Mar 201815 Nov 2018

First posted16 Mar 2018
Study start8 Mar 2018
Primary completion15 Nov 2018
Study completion15 Nov 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.
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: Phase 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03467477
Sponsor's protocol ID: 18F-AV-1451-A24
Status last verified: Aug 2020
First submitted: 8 Mar 2018
Last updated: 24 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Screening Study With Flortaucipir F 18 in Patients With Early Symptomatic AD; #2
ClinicalTrials.gov ID: NCT03467477
Acronym / sponsor ID: 18F-AV-1451-A24
Conditions: Alzheimer Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 8 Mar 2018 (actual)
Primary completion: 15 Nov 2018 (actual)
Study completion: 15 Nov 2018 (actual)
First posted: 16 Mar 2018 (actual)
Results: Posted 24 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

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

Arm	Type	Receives
Flortaucipir PET Scan	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET Scan

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (31 listed)

Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. 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;
Patients who lack, in the investigator's opinion, adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric testing;
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);
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.];
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 life expectancy of <24 months;

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, LY3191748370 megabecquerel (MBq) IV single-dose	Drug	Flortaucipir PET Scan
Brain PET Scanpositron emission tomography (PET) scan of the brain	Procedure or surgery	Flortaucipir PET Scan

Primary outcome

Flortaucipir Qualitative Results (Visual Reads)
Time frame: baseline scan
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.
Flortaucipir Quantitative Results (SUVr)
Time frame: baseline scan
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.

Results and safety

Results posted to the registry on 24 Aug 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
Early Symptomatic AD Subjects	161	161

Primary outcome: Flortaucipir Qualitative Results (Visual Reads)

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

Measure	Early Symptomatic AD, Eligible for Future Trials n = 55	Early Symptomatic AD, Ineligible for Future Trials n = 105	Early Symptomatic AD, Not Evaluable n = 1	Early Symptomatic AD (Total) n = 161
τAD++, advanced AD pattern	51	13	1	65
τAD+, moderate AD pattern	4	10	0	14
τAD-, pattern not consistent with AD	0	82	0	82

Primary outcome: Flortaucipir Quantitative Results (SUVr)

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

Measure	Early Symptomatic AD, Eligible for Future Trials n = 55	Early Symptomatic AD, Ineligible for Future Trials n = 23	Early Symptomatic AD, Not Evaluable n = 1	Early Symptomatic AD (Total) n = 78
SUVr all subjects	1.24766 (0.122786)	1.38020 (0.343791)	–	1.28674 (0.219185)
SUVr τAD++ subjects	1.25687 (0.122501)	1.64935 (0.187100)	–	1.33659 (0.209539)
SUVr τAD+ subjects	1.13025 (0.038043)	1.03031 (0.039727)	–	1.05886 (0.060181)

Population analysed: SUVr was not collected for patients with a τAD- result (n=82) and one subject had an unevaluable flortaucipir scan for quantitation. Therefore, analysis population n=78.

Adverse events

Time frame: 48 hours after study drug administration. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Analysis Population	0 of 161 (0%)	2 of 161 (1.2%)	0 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Flortaucipir F18 and Brain PET Scan in people with Alzheimer Disease, run by Avid Radiopharmaceuticals at 9 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 5 inclusion and 31 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 24 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 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 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 Qualitative Results (Visual Reads) (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 NCT03467477.

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 24 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.