Alzheimer's DiseasePhase 2NCT00702143

A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

A Phase 2 study testing florbetapir F 18 in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Avid Radiopharmaceuticals at 15 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

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI). Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer's Disease, Mild Cognitive Impairment
What is being tested?: florbetapir F 18
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 15 sitesUnited States
Study dates: Jun 2008to Dec 2008
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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female >=50 years of age
Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24
Male or female >=50 years of age
Have a Clinical Dementia Rating (CDR) of 0.5
MMSE >24
Normal subjects:

Show all 10Show fewer

Male or female >=50 years of age
MMSE >=29
Normal on psychometric test battery at screening
Provide informed consent

Who cannot join

Have a history or current diagnosis of other neurologic disease
Have had or currently have a diagnosis of other neurodegenerative disease
Have participated in experimental therapy targeted to amyloid plaque

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Research Site
Albany, New York, 12208
Research Site
Bennington, Vermont, 05201
Research Site
Costa Mesa, California, 92626
Research Site
Hallandale, Florida, 33064
Research Site
Jenkintown, Pennsylvania, 19046
Research Site
Miami Beach, Florida, 33140
Research Site
New Haven, Connecticut, 06510
Research Site
Phoenix, Arizona, 85006
Research Site
Scottsdale, Arizona, 85252
Research Site
St. Petersburg, Florida, 33702
Research Site
Sun City, Arizona, 85210
Research Site
Sunrise, Florida, 33351
Research Site
Tucson, Arizona, 85741
Research Site
West Palm Beach, Florida, 33407
Research Site
Winston-Salem, North Carolina, 27103

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About this study

Official title: An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Conditions: Alzheimer's Disease, Mild Cognitive Impairment
Being tested: florbetapir F 18
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.

florbetapir F 18Drug
Also called 18F-AV-45, Amyvid, florbetapir
IV injection, 370MBq (10mCi), single dose

Study groups in NCT00702143
Study group	Role	What they receive
AD subjects	Experimental	Not described Receives: Drug: florbetapir F 18
MCI Subjects	Experimental	MCI (mild cognitive impairment) Receives: Drug: florbetapir F 18
Healthy controls	Experimental	Not described Receives: Drug: florbetapir F 18

What is being measured

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

Qualitative Amyloid Image Assessment
Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Measured: 50-60 min after injection
Mean Cortical to Cerebellum SUVR
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Measured: 50-60 min after injection

Secondary outcomes (1)

Proportion of Positive Florbetapir-PET Scans
Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.
Measured: 50-60 min after injection

Timeline

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

Jun 2008Dec 2008

First posted20 Jun 2008 (estimated)
Study startJun 2008
Primary completionDec 2008
Study completionDec 2008

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'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 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00702143
Sponsor's protocol ID: 18F-AV-45-A05
Status last verified: May 2012
First submitted: 19 Jun 2008
Last updated: 10 May 2012
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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
ClinicalTrials.gov ID: NCT00702143
Acronym / sponsor ID: 18F-AV-45-A05
Conditions: Alzheimer's Disease, Mild Cognitive Impairment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 20 Jun 2008 (estimated)
Results: Posted 3 May 2012

Clinical summary

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

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AD subjects	Experimental	Drug: florbetapir F 18
MCI Subjects	Experimental	Drug: florbetapir F 18MCI (mild cognitive impairment)
Healthy controls	Experimental	Drug: florbetapir F 18

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female >=50 years of age
Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24
Male or female >=50 years of age
Have a Clinical Dementia Rating (CDR) of 0.5
MMSE >24

Key exclusion criteria (3 listed)

Have a history or current diagnosis of other neurologic disease
Have had or currently have a diagnosis of other neurodegenerative disease
Have participated in experimental therapy targeted to amyloid plaque

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 F 18Also: 18F-AV-45, Amyvid, florbetapirIV injection, 370MBq (10mCi), single dose	Drug	AD subjects, Healthy controls, MCI Subjects

Primary outcome

Qualitative Amyloid Image Assessment
Time frame: 50-60 min after injection
Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Mean Cortical to Cerebellum SUVR
Time frame: 50-60 min after injection
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

1 secondary outcome

Proportion of Positive Florbetapir-PET Scans
Time frame: 50-60 min after injection

Results and safety

Results posted to the registry on 3 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AD Subjects	45	45
MCI Subjects	60	60
Healthy Controls	79	78

Primary outcome: Qualitative Amyloid Image Assessment

Time frame: 50-60 min after injection. Number. Unit: participants

Measure	AD Subjects n = 45	MCI Subjects n = 60	Healthy Controls n = 78
Positive for amyloid	34	23	11
Negative for amyloid	11	37	67

AD Subjects vs MCI Subjects: p = 0.0002, Fisher Exact
AD Subjects vs Healthy Controls: p <0.0001, Fisher Exact
MCI Subjects vs Healthy Controls: p = 0.0014, Fisher Exact

Population analysed: One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.

Primary outcome: Mean Cortical to Cerebellum SUVR

Time frame: 50-60 min after injection. Mean (Standard Deviation). Unit: SUVR

Measure	AD Subjects n = 45	MCI Subjects n = 60	Healthy Controls n = 78
Value	1.404 (0.2670)	1.199 (0.2761)	1.051 (0.1585)

AD Subjects vs MCI Subjects vs Healthy Controls: p <0.0001, ANOVA
AD Subjects vs MCI Subjects: p <0.0001, ANOVA
AD Subjects vs Healthy Controls: p <0.0001, ANOVA

Population analysed: One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected up to 7 days after injection. SAEs were collected up to 30 days after injection.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	1 of 184 (0.5%)	2 of 184 (1.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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 director

Avid Radiopharmaceuticals

15 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 florbetapir F 18 in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Avid Radiopharmaceuticals at 15 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 10 inclusion and 3 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 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 3 May 2012). 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?

Qualitative Amyloid Image Assessment (time frame: 50-60 min after injection). 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 NCT00702143.

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 10 May 2012.