Alzheimer DiseasePhase 2NCT03322462
Tau Screening Study in Patients 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 10 sites in 2 countries.
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
- 155 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 21 Nov 2017to 31 Aug 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
- Men or women between the ages of 60 and 85 years of age at the time of consent
- Patients with gradual and progressive change in memory function for a period equal to or greater than six months
- Patients who have a Mini Mental State Examination (MMSE) score in the 20-27 range
- 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) to consent for enrollment
Who cannot join
- Patients who lack adequate premorbid literacy, vision, or hearing to complete the required psychometric testing in the investigator's opinion
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception methods. Females of childbearing potential must not be pregnant (negative serum β-Human Chorionic Gonadotropin [HCG] 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 flortaucipir F 18 injection administration.
- 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 types of dementia, serious brain infections, 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 opinion of the investigator, the disorder/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).
- 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 du Pointes.
- Have an average electrocardiography (ECG) corrected QT (QTcF) interval measurement > 450 msec (men) or > 470 msec (women) at screening (as determined at the investigational site).
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- Have ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
- Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit
- Have a current serious or unstable illness including retinal, 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 less than 24 months.
- Has a history of cancer within the last five years, with the exception of non-metastatic 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
- Patients with a past history (suspected or confirmed) of Hepatitis B or Hepatitis C
- History of vitiligo and/or current evidence of post-inflammatory hypopigmentation
- Have had prior treatment with a passive anti-amyloid immunotherapy less than five half-lives prior to randomization.
- Have previously participated in any other study investigating active immunization against amyloid beta (Aβ)
- 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
- Contraindication to PET
- Has hypersensitivity to flortaucipir F 18 or any of its excipients
- 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
- Has previous magnetic resonance imaging (MRI) evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact patient's potential to safely participate in study
- Have contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
- Have poor venous access
- Are investigator site personnel directly affiliated with this study and/or immediate families; immediate family is defined as a spouse, parent, child, or sibling (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
- Are otherwise unsuitable for a study of this type in the opinion of the investigator
- Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than two months before randomization (if a patient has recently stopped an AChEI and/or memantine, he/she must have discontinued treatment at least two months before randomization).
- Current use of strong inducers of CYP3A
- Are currently on medication(s) known to significantly prolong the QT interval
- Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- Have known allergies to LY3002813, related compounds, or any components of the formulation; or history of significant atopy
- Have known allergies to LY3202626, related compounds, or any components of the formulation
- Changes in concomitant medications that could potentially affect cognition and their dosing should be stable for at least one month before screening, and between screening and randomization (does not apply to medications discontinued due to exclusions or with limited duration of use, such as antibiotics)
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
The Memory Clinic
Bennington, Vermont, 05201
Brain Matters Research
Delray Beach, Florida, 33445
Boston Center for Memory
Newton, Massachusetts, 02459
Bioclinica (Compass Research)
Orlando, Florida, 32806
Pacific Research Network
San Diego, California, 92103
Syrentis Clinical Research
Santa Ana, California, 92705
Axiom Clinical Research
Tampa, Florida, 33609
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090
PMG Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter Screening Study With Flortaucipir F 18 in Patients With Early Symptomatic AD
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.
- 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
370 megabecquerel (MBq) IV single-dose
Brain PET ScanProcedure or surgery
positron emission tomography (PET) scan of the brain
| 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 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.
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. 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.
Measured: baseline scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start21 Nov 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 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
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322462
- Sponsor's protocol ID
- 18F-AV-1451-A23
- Status last verified
- Aug 2020
- First submitted
- 16 Oct 2017
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
- ClinicalTrials.gov ID
- NCT03322462
- Acronym / sponsor ID
- 18F-AV-1451-A23
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 26 Oct 2017 (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.
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.
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)
- Men or women between the ages of 60 and 85 years of age at the time of consent
- Patients with gradual and progressive change in memory function for a period equal to or greater than six months
- Patients who have a Mini Mental State Examination (MMSE) score in the 20-27 range
- 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) to consent for enrollment
Key exclusion criteria (31 listed)
- Patients who lack adequate premorbid literacy, vision, or hearing to complete the required psychometric testing in the investigator's opinion
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception methods. Females of childbearing potential must not be pregnant (negative serum β-Human Chorionic Gonadotropin [HCG] 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 flortaucipir F 18 injection administration.
- 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 types of dementia, serious brain infections, 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 opinion of the investigator, the disorder/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).
- 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 du Pointes.
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]T807370 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 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.
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. 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.
Results and safety
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.
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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
10 sites in 2 countries: 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 10 sites in 2 countries.
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 10 sites in United States, Canada. 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?
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.