Alzheimer's DiseaseNCT01565356
Evaluation of PET Scan Timing Relative to AV-45 Injection Time
A study testing florbetapir F 18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals.
Trial summary
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- florbetapir F 18
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2010
- Phase
- Interventional
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than 50 years of age
- Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
- History of cognitive decline gradual in onset and progressive over a period of at least 6 months
- Inclusion Criteria (A01[NCT01565291] healthy volunteer group):
- 50 years of age, inclusive
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- MMSE of 29 or greater
- Inclusion Criteria (A03[NCT01565330] healthy volunteer group):
- 35 to 55 years of age, inclusive
- MMSE of 29 or greater
Who cannot join
- Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
- Diagnosis of other dementing / neurodegenerative disease
- Diagnosis of mixed dementia
- Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
- Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
- Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
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- Clinically significant psychiatric disease
- History of epilepsy or convulsions
- Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Current clinically significant cardiovascular disease
- Received investigational medication within the last 30 days
About this study
Official title: Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.
- Conditions
- Alzheimer's Disease
- Being tested
- florbetapir F 18
- Keywords
- Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
- 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 F 18Drug
Also called 18F-AV-45, Amyvid, florbetapir
IV injection, 111 or 370MBq (3 or 10mCi), single dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.
Measured: Scans acquired 30-40 min and 50-60 min after injection
Secondary outcomes (1)
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.
Measured: Scans acquired 30-40 min and 50-60 min post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565356
- Sponsor's protocol ID
- 18F-AV-45-A06
- Status last verified
- May 2012
- First submitted
- 26 Mar 2012
- Last updated
- 7 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT01565356
- Acronym / sponsor ID
- 18F-AV-45-A06
- Conditions
- Alzheimer's Disease
- Keywords
- Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 7 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Greater than 50 years of age
- Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
- History of cognitive decline gradual in onset and progressive over a period of at least 6 months
- 50 years of age, inclusive
Key exclusion criteria (11 listed)
- Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
- Diagnosis of other dementing / neurodegenerative disease
- Diagnosis of mixed dementia
- Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
- Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
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, 111 or 370MBq (3 or 10mCi), single dose | Drug | – |
Primary outcome
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
Time frame: Scans acquired 30-40 min and 50-60 min after injection
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.
1 secondary outcome
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation
Time frame: Scans acquired 30-40 min and 50-60 min post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 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
Questions about this trial
What is this clinical trial studying?
A study testing florbetapir F 18 in people with Alzheimer's Disease, 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 10 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 7 Jun 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 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?
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation (time frame: Scans acquired 30-40 min and 50-60 min after injection). 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 7 Jun 2012.