Alzheimer DiseasePhase 1NCT04468347

Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer Disease and Mild Cognitive Impairment, run by Avid Radiopharmaceuticals.

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

A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease, Mild Cognitive Impairment
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: 89 participants
Where: No sites listed yet
Study dates: Oct 2014to Feb 2018
Phase: 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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms

Who cannot join

lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
history of electroconvulsive therapy
MRI contraindicated
claustrophobic or, otherwise, unable to tolerate the imaging procedure
current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
history of additional risk factors for Torsades de Pointes

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current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
current drug or alcohol abuse/dependence
history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception

About this study

Official title: 18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.

Read the detailed description

The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving research centers in both Victoria and Western Australia. The goal of the A08 protocol was to further investigate the positron emission tomography (PET) imaging results with flortaucipir in patients across the AD spectrum from individuals with subjective memory complaints (SMC) to those with dementia, based on recruitment into the parent AIBL study.

Conditions: Alzheimer Disease, Mild Cognitive Impairment
Being tested: Flortaucipir F18, Brain PET scan
Medical subject headings: Alzheimer Disease, Cognitive Dysfunction

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, 240 megabecquerel (MBq) (6.5 mCi)
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain

Study groups in NCT04468347
Study group	Role	What they receive
Alzheimer's disease (AD)	Experimental	Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan
Mild cognitive impairment (MCI)	Experimental	Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan
Subjective memory complainers (SMC)	Experimental	Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan
Cognitively normal (CN)	Experimental	Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months 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 PET Imaging (Quantitative)
Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: baseline scan
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
Measured: baseline scan
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
Measured: baseline scan

Timeline

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

Oct 2014Feb 2018

First posted13 Jul 2020
Study startOct 2014
Primary completionFeb 2018
Study completionFeb 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 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04468347
Sponsor's protocol ID: 18F-AV-1451-A08
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: No
FDA-regulated device: 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?

Official record

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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: 18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
ClinicalTrials.gov ID: NCT04468347
Acronym / sponsor ID: 18F-AV-1451-A08
Conditions: Alzheimer Disease, Mild Cognitive Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2014 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Feb 2018 (actual)
First posted: 13 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.

A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Alzheimer's disease (AD)	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanAlzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
Mild cognitive impairment (MCI)	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanMild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
Subjective memory complainers (SMC)	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanSubjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
Cognitively normal (CN)	Experimental	Drug: Flortaucipir F18, Procedure: Brain PET scanCognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms

Key exclusion criteria (11 listed)

lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
history of electroconvulsive therapy
MRI contraindicated
claustrophobic or, otherwise, unable to tolerate the imaging procedure
current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram

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, 240 megabecquerel (MBq) (6.5 mCi)	Drug	Alzheimer's disease (AD), Cognitively normal (CN), Mild cognitive impairment (MCI), Subjective memory complainers (SMC)
Brain PET scanpositron emission tomography (PET) scan of the brain	Procedure or surgery	Alzheimer's disease (AD), Cognitively normal (CN), Mild cognitive impairment (MCI), Subjective memory complainers (SMC)

Primary outcome

Flortaucipir PET Imaging (Quantitative)
Time frame: baseline scan
Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Time frame: baseline scan
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Time frame: baseline scan
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.

Results and safety

Results posted to the registry on 25 Sep 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
Alzheimer's Disease (AD)	6	4
Mild Cognitive Impairment (MCI)	11	10
Subjective Memory Complainers (SMC)	47	41
Cognitively Normal (CN)	25	21

Primary outcome: Flortaucipir PET Imaging (Quantitative)

Time frame: baseline scan. Least squares mean (Standard Error). Unit: standardized uptake value ratio (SUVr)

Measure	Alzheimer's Disease (AD) n = 4	Mild Cognitive Impairment (MCI) n = 10	Objectively Impaired n = 14	Subjective Memory Complainers (SMC) n = 40	Cognitively Normal (CN) n = 22	Non-objectively Compared n = 62
Value	1.31 (0.059)	1.13 (0.033)	1.15 (0.031)	1.08 (0.016)	1.04 (0.028)	1.07 (0.015)

Objectively Impaired vs Non-objectively Compared: Mean Difference (Net): 0.16, p <0.0001, ANOVA
Objectively Impaired vs Subjective Memory Complainers (SMC): Mean Difference (Net): 0.14, p = 0.0005, ANOVA
Subjective Memory Complainers (SMC) vs Cognitively Normal (CN): Mean Difference (Net): -0.04, p = 0.2161, ANOVA

Population analysed: Inclusion in this analysis required that the subject's flortaucipir scan was analyzable for SUVr (1 AD, 1 MCI, 5 SMC, and 3 CN were not analyzable)

Primary outcome: Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status

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

Measure	Alzheimer's Disease (AD) n = 5	Mild Cognitive Impairment (MCI) n = 11	Subjective Memory Complainers (SMC) n = 45	Cognitively Normal (CN) n = 25
Amyloid Positive: Advanced AD Scan Pattern (τAD++)	2	3	9	0
Amyloid Positive: Not Advanced AD Pattern	2	2	11	4
Amyloid Negative: Advanced AD Scan Pattern (τAD++)	1	0	3	1
Amyloid Negative: Not Advanced AD Pattern	0	6	22	20

Alzheimer's Disease (AD) vs Mild Cognitive Impairment (MCI) vs Subjective Memory Complainers (SMC) vs Cognitively Normal (CN): p = 0.1998, Cochran-Mantel-Haenszel

Population analysed: Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline

Primary outcome: Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status

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

Measure	Alzheimer's Disease (AD) n = 5	Mild Cognitive Impairment (MCI) n = 11	Subjective Memory Complainers (SMC) n = 45	Cognitively Normal (CN) n = 25
Amyloid Positive: AD Pattern Scan (Advanced or Moderate)	2	4	11	0
Amyloid Positive: Not AD Pattern Scan	2	1	9	4
Amyloid Negative: AD Pattern Scan (Advanced or Moderate)	1	0	6	1
Amyloid Negative: Not AD Pattern Scan	0	6	19	20

Alzheimer's Disease (AD) vs Mild Cognitive Impairment (MCI) vs Subjective Memory Complainers (SMC) vs Cognitively Normal (CN): p = 0.0646, Cochran-Mantel-Haenszel

Population analysed: Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline.

Adverse events

Time frame: End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alzheimer's Disease (AD)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Mild Cognitive Impairment (MCI)	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Subjective Memory Complainers (SMC)	0 of 45 (0%)	1 of 45 (2.2%)	0 of 45
Cognitively Normal (CN)	0 of 25 (0%)	1 of 25 (4%)	0 of 25

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.
Link to the Australian Imaging, Biomarker \& Lifestyle Flagship Study of Ageing (AIBL) websiteLink provided by the sponsor.

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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 director

Avid Radiopharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer Disease and Mild Cognitive Impairment, run by Avid Radiopharmaceuticals.

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 2 inclusion and 11 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.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Flortaucipir PET Imaging (Quantitative) (time frame: baseline scan). The study lists 3 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 NCT04468347.

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.