Alzheimer DiseaseEarly Phase 1NCT01565291
A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers
A Early Phase 1 study testing florbetapir F 18 in people with Alzheimer Disease, run by Avid Radiopharmaceuticals at 3 sites in United States.
Trial summary
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- 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
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to Jan 2008
- Phase
- Early 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
- History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months
- No evidence of significant cognitive impairment by history and psychometric testing
- MMSE of 29 or higher
Who cannot join
- Neurodegenerative disorders other than AD
- 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)
- Clinically significant psychiatric disease
- History of epilepsy or convulsions
Show all 9Show fewer
- Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Current clinically significant cardiovascular disease
- Received investigational medication within the last 30 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Baltimore, Maryland, 21287
Research Site
Long Branch, New Jersey, 07740
Research Site
North East, Maryland, 21901
About this study
Official title: A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.
- Conditions
- Alzheimer 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, 370MBq (10mCi), single dose
| Study group | Role | What they receive |
|---|---|---|
| Subjects With AD | Experimental | Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24) Receives: Drug: florbetapir F 18 |
| Healthy Elderly Subjects | Experimental | Cognitively normal with MMSE of 29 or higher; age 50 years or older Receives: Drug: florbetapir F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 cerebellum gray matter. Total scan length was 200 min.
Measured: 50-60 min after injection
Secondary outcomes (1)
Precuneus to Cerebellum SUVR
Ratio of uptake in the precuneus to uptake in the cerebellum.
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.
- First posted28 Mar 2012 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJan 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT01565291
- Sponsor's protocol ID
- 18F-AV-45-A01
- Status last verified
- May 2012
- First submitted
- 25 Mar 2012
- Last updated
- 18 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wong DF, Rosenberg PB, Zhou Y, Kumar A, Raymont V, Ravert HT, Dannals RF, Nandi A, Brasic JR, Ye W, Hilton J, Lyketsos C, Kung HF, Joshi AD, Skovronsky DM, Pontecorvo MJ. In vivo imaging of amyloid deposition in Alzheimer disease using the radioligand 18F-AV-45 (florbetapir [corrected] F 18). J Nucl Med. 2010 Jun;51(6):913-20. doi: 10.2967/jnumed.109.069088.
PubMed 20501908
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01565291
- Acronym / sponsor ID
- 18F-AV-45-A01
- Conditions
- Alzheimer Disease
- Keywords
- Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 28 Mar 2012 (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.
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects With AD | Experimental | Drug: florbetapir F 18Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24) |
| Healthy Elderly Subjects | Experimental | Drug: florbetapir F 18Cognitively normal with MMSE of 29 or higher; age 50 years or older |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
- History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months
- No evidence of significant cognitive impairment by history and psychometric testing
- MMSE of 29 or higher
Key exclusion criteria (9 listed)
- Neurodegenerative disorders other than AD
- 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)
- Clinically significant psychiatric disease
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 | Healthy Elderly Subjects, Subjects With AD |
Primary outcome
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 cerebellum gray matter. Total scan length was 200 min.
1 secondary outcome
Precuneus to Cerebellum SUVR
Time frame: 50-60 min after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20501908Wong DF, Rosenberg PB, Zhou Y, Kumar A, Raymont V, Ravert HT, Dannals RF, Nandi A, Brasic JR, Ye W, Hilton J, Lyketsos C, Kung HF, Joshi AD, Skovronsky DM, Pontecorvo MJ. In vivo imaging of amyloid deposition in Alzheimer disease using the radioligand 18F-AV-45 (florbetapir [corrected] F 18). J Nucl Med. 2010 Jun;51(6):913-20. doi: 10.2967/jnumed.109.069088.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing florbetapir F 18 in people with Alzheimer Disease, run by Avid Radiopharmaceuticals at 3 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 5 inclusion and 9 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 18 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 3 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Mean Cortical to Cerebellum SUVR (time frame: 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?
On the ClinicalTrials.gov record for NCT01565291, 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 18 May 2012.