Alzheimer's DiseasePhase 1NCT02120664

Florbetapir Calibration to the Centiloid Scale

A Phase 1 study testing Florbetapir (18F) and 11C-PiB in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 sites in 2 countries.

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 study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer's Disease
What is being tested?: Florbetapir (18F) and 11C-PiB
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 2 sitesin 2 countries
Study dates: Apr 2014to Sep 2015
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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Cognitively Normal Subjects
Males or females ≥ 21 and ≤ 45 years of age
Mini-mental state examination (MMSE) ≥ 29
Clinically Diagnosed AD Subject
Males or females ≥ 50 years of age
Meet clinical criteria for dementia due to probable AD

Show all 17Show fewer

MMSE ≥ 16 and ≤ 26
Possible AD Subject
Males or females ≥ 50 years of age
Meet clinical criteria for dementia due to possible AD
MMSE ≥ 16 and ≤ 26
MCI Subject
Males or females ≥ 60 years of age with cognitive impairment (not dementia)
MMSE >24 and <29
At Risk Elderly Subject
Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
MMSE ≥ 27

Who cannot join

Have had or currently have a diagnosis of neurodegenerative disorders other than AD
Have a current serious or unstable illness that could interfere with completion of the study
Subject has a known brain lesion, pathology or traumatic brain injury
Have received or participated in a trial with investigational medications in the past 30 days
Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Research Site
Pittsburgh, Pennsylvania, 15213

Other trials in United States

Australia1 site

Research Site
Heidelberg, Victoria, 3084

Other trials in Australia

About this study

Official title: A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

Conditions: Alzheimer's Disease
Being tested: Florbetapir (18F), 11C-PiB
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Florbetapir (18F)Drug
Also called Florbetapir F 18, Amyvid, 18F-AV-45
11C-PiBDrug
Also called Pittsburgh Compound B

Study groups in NCT02120664
Study group	Role	What they receive
Amyloid Negative Subjects	Experimental	Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. Receives: Drug: Florbetapir (18F); Drug: 11C-PiB
Amyloid Positive Subjects	Experimental	Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. Receives: Drug: Florbetapir (18F); Drug: 11C-PiB

What is being measured

The primary outcome is the main question the study is designed to answer.

Florbetapir SUVr Conversion to Centiloid Units
Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.
Measured: up to 70 minutes post injection

Secondary outcomes (2)

Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.
Measured: up to 70 minutes post injection
Variability of PET Images in Young Healthy Control Subjects.
Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.
Measured: up to 70 minutes post injection

Timeline

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

Apr 2014Sep 2015

First posted23 Apr 2014 (estimated)
Study startApr 2014
Primary completionSep 2015
Study completionSep 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alzheimer's 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02120664
Sponsor's protocol ID: 18F-AV-45-A22
Status last verified: Jan 2017
First submitted: 17 Apr 2014
Last updated: 9 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003. Epub 2014 Oct 28.
PubMed 25443857

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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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB
ClinicalTrials.gov ID: NCT02120664
Acronym / sponsor ID: 18F-AV-45-A22
Conditions: Alzheimer's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 23 Apr 2014 (estimated)
Results: Posted 9 Mar 2017

Clinical summary

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

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Amyloid Negative Subjects	Experimental	Drug: Florbetapir (18F), Drug: 11C-PiBApproximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
Amyloid Positive Subjects	Experimental	Drug: Florbetapir (18F), Drug: 11C-PiBApproximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Cognitively Normal Subjects
Clinically Diagnosed AD Subject
Possible AD Subject
MCI Subject
At Risk Elderly Subject

Key exclusion criteria (6 listed)

Have had or currently have a diagnosis of neurodegenerative disorders other than AD
Have a current serious or unstable illness that could interfere with completion of the study
Subject has a known brain lesion, pathology or traumatic brain injury
Have received or participated in a trial with investigational medications in the past 30 days
Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session

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
Florbetapir (18F)Also: Florbetapir F 18, Amyvid, 18F-AV-45	Drug	Amyloid Negative Subjects, Amyloid Positive Subjects
11C-PiBAlso: Pittsburgh Compound B	Drug	Amyloid Negative Subjects, Amyloid Positive Subjects

Primary outcome

Florbetapir SUVr Conversion to Centiloid Units
Time frame: up to 70 minutes post injection
Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.

2 secondary outcomes

Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
Time frame: up to 70 minutes post injection
Variability of PET Images in Young Healthy Control Subjects.
Time frame: up to 70 minutes post injection

Results and safety

Results posted to the registry on 9 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clincally Diagnosed AD	10	10
Possible AD	4	4
Mild Cognitive Impairment (MCI)	7	7
At Risk Elderly	4	3
Young Healthy Controls (YHC)	10	10

Primary outcome: Florbetapir SUVr Conversion to Centiloid Units

Time frame: up to 70 minutes post injection. Mean (Standard Deviation). Unit: centiloid

Measure	Clincally Diagnosed AD n = 10	Possible AD n = 3	Mild Cognitive Impairment (MCI) n = 7	At Risk Elderly n = 3	Young Healthy Controls (YHC) n = 10
Value	82.44 (45.623)	50.75 (60.383)	81.19 (66.357)	14.93 (35.885)	5.24 (11.981)

Population analysed: All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete a florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: within 48 hours of scan as noted by group title. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Florbetapir Only	0 of 34 (0%)	0 of 34 (0%)	Not reported
PiB Only	0 of 35 (0%)	0 of 35 (0%)	Not reported
Both	0 of 34 (0%)	0 of 34 (0%)	Not reported
Total	0 of 34 (0%)	0 of 34 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25443857Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003. Epub 2014 Oct 28.

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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

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Florbetapir (18F) and 11C-PiB in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 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 17 inclusion and 6 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Australia. 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 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 9 Mar 2017). 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?

Florbetapir SUVr Conversion to Centiloid Units (time frame: up to 70 minutes post injection). 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 NCT02120664, which also lists 1 linked publication.

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 9 Mar 2017.