HealthyPhase 3NCT01265394

Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects

A Phase 3 study testing [18F] Flutemetamol in people with Healthy, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: [18F] Flutemetamol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 218 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Apr 2011
Phase: Phase 3
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

The subject age is 18 to 40 years.
The subject has no evidence of thinking or memory problems by medical history.
The subject has a normal MRI scan.
The subject's general health is adequate to comply with study procedures.
The subject is willing and able to participate in all study procedures.

Who cannot join

The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
The subject has a contraindication for (cannot undergo) MRI.
The subject has a history of head injury with loss of consciousness.
The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40

Conditions: Healthy
Being tested: [18F] Flutemetamol
Keywords: Amyloid, Magnetic resonance imaging, Positron Emission Tomography, Standard uptake value ratios, Healthy Subjects
Medical subject headings: Alzheimer Disease

What participants receive

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

[18F] FlutemetamolDrug
Also called AH110690
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.

Study groups in NCT01265394
Study group	Role	What they receive
(18F) Flutemetamol	Experimental	Not described Receives: Drug: [18F] Flutemetamol

What is being measured

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

Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.
The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).
Measured: PET scans performed on patients 90 minutes post Flutemetmol Administration

Secondary outcomes (1)

Measurement of Amyloid Content in Different Parts of the Brain
Is the computerized measurement of amyloid content in different parts of the brain.
The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.
The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.
The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.
Measured: PET scans performed on patients 90 minutes post Flutemetmol Administration

Timeline

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

Dec 2010Apr 2011

First posted23 Dec 2010 (estimated)
Study startDec 2010
Primary completionMar 2011
Study completionApr 2011

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 HealthyStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
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 3
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01265394
Sponsor's protocol ID: GE-067-015
Status last verified: Jun 2013
First submitted: 21 Dec 2010
Last updated: 2 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
ClinicalTrials.gov ID: NCT01265394
Acronym / sponsor ID: GE-067-015
Conditions: Healthy
Keywords: Amyloid, Magnetic resonance imaging, Positron Emission Tomography, Standard uptake value ratios, Healthy Subjects
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: i3 Statprobe, Medpace, Inc.
Study start: Dec 2010
Primary completion: Mar 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 23 Dec 2010 (estimated)
Results: Posted 21 Jun 2013

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
(18F) Flutemetamol	Experimental	Drug: [18F] Flutemetamol

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

The subject age is 18 to 40 years.
The subject has no evidence of thinking or memory problems by medical history.
The subject has a normal MRI scan.
The subject's general health is adequate to comply with study procedures.
The subject is willing and able to participate in all study procedures.

Key exclusion criteria (5 listed)

The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
The subject has a contraindication for (cannot undergo) MRI.
The subject has a history of head injury with loss of consciousness.
The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

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
[18F] FlutemetamolAlso: AH110690Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.	Drug	(18F) Flutemetamol

Primary outcome

Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
Time frame: PET scans performed on patients 90 minutes post Flutemetmol Administration
The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).

1 secondary outcome

Measurement of Amyloid Content in Different Parts of the Brain
Time frame: PET scans performed on patients 90 minutes post Flutemetmol Administration

Results and safety

Results posted to the registry on 21 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
(18F) Flutemetamol	218	181

Primary outcome: Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid

Time frame: PET scans performed on patients 90 minutes post Flutemetmol Administration. Number. Unit: Brain Scans Read

Measure	Normal and Abnormal Reads With or Without Amyloid n = 181
Reader 1 -Normal Read-no amyloid	181 (98.0 to 100.0)
Reader 1- Abnormal Read- amyloid is present	0 (60.6 to 74.7)
Reader 2 - Normal Read-no amyloid	123 (97.0 to 100.0)
Reader 2 - Abnormal Read-amyloid is present	58 (97.0 to 100.0)
Reader 3 - Normal Read-no amyloid	180 (96.1 to 99.9)
Reader 3 - Abnormal Read-amyloid is present	1
Reader 4 - Normal Read-no amyloid	180
Reader 4 - Abnormal Read-amyloid is present	1

Population analysed: Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
(18F) Flutemetamol	0 of 181 (0%)	27 of 181 (14.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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.

Paul Sherwin, MD, PhD study director

GE Healthcare

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [18F] Flutemetamol in people with Healthy, run by GE Healthcare at 1 site 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 5 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Jun 2013). 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?

Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid (time frame: PET scans performed on patients 90 minutes post Flutemetmol Administration). 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 NCT01265394.

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 2 Jul 2013.