Dementia With Lewy BodiesPhase 1/2NCT01503944
A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)
A Phase 1/2 study testing 18F-AV-133 and 18F-AV-45 in people with Dementia With Lewy Bodies and Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease
- What is being tested?
- 18F-AV-133 and 18F-AV-45
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)
- Male or female > 50 years of age
- Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
- Male or female > 50 years of age
- Have probable PD according to the following criteria (Gelb et al., 1999):
Show all 15Show fewer
- Presence of 2 of the following 3 features: rest tremor, rigidity, bradykinesia;
- Documented history of a sustained (>6 months) improvement to Levodopa (L-DOPA) or a dopamine agonist
- Absence of atypical clinical features or other possible signs or symptoms suggesting another cause of parkinsonism such as a history of frequent falls as a prominent early feature, localized brain lesion(s) or neuroleptic use
- Asymmetric onset
- A diagnosis of PD made within the 4 years prior to enrollment
- Normal subjects:
- Are males or females > 50 years of age
- Have a MMSE score > 29, and are cognitively normal on the psychometric test battery at screening
- Have no signs or symptoms of clinically meaningful parkinsonism
Who cannot join
- Have a history or current diagnosis of other neurologic disease
- Have evidence of clinically significant cerebrovascular disease
- Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Philadelphia, Pennsylvania
Research Site
Sun City, Arizona
About this study
Official title: Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly Volunteers
The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.
- Being tested
- 18F-AV-133, 18F-AV-45
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-133Drug
185 MBq
18F-AV-45Drug
185-370 MBq
| Study group | Role | What they receive |
|---|---|---|
| Dementia with Lewy Bodies | Other | Not described Receives: Drug: 18F-AV-133; Drug: 18F-AV-45 |
| Parkinson's disease | Other | Not described Receives: Drug: 18F-AV-133; Drug: 18F-AV-45 |
| Healthy Elderly Volunteers | Other | Not described Receives: Drug: 18F-AV-133; Drug: 18F-AV-45 |
| Alzheimer's Disease | Other | Not described Receives: Drug: 18F-AV-133; Drug: 18F-AV-45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-AV-133 striatal to occipital standard uptake value ratio
The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region
Measured: Four Weeks
Secondary outcomes (1)
18F-AV-45 cortical to cerebellar standard uptake value ratio
The ratio of tracer activity in cortical target areas of interest relative to the cerebellum reference region
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01503944
- Sponsor's protocol ID
- 18F-AV-133-B03
- Status last verified
- Aug 2012
- First submitted
- 14 Jul 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly Volunteers
- ClinicalTrials.gov ID
- NCT01503944
- Acronym / sponsor ID
- 18F-AV-133-B03
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dementia with Lewy Bodies | Other | Drug: 18F-AV-133, Drug: 18F-AV-45 |
| Parkinson's disease | Other | Drug: 18F-AV-133, Drug: 18F-AV-45 |
| Healthy Elderly Volunteers | Other | Drug: 18F-AV-133, Drug: 18F-AV-45 |
| Alzheimer's Disease | Other | Drug: 18F-AV-133, Drug: 18F-AV-45 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female > 50 years of age
- Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)
- Male or female > 50 years of age
- Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
- Male or female > 50 years of age
Key exclusion criteria (3 listed)
- Have a history or current diagnosis of other neurologic disease
- Have evidence of clinically significant cerebrovascular disease
- Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases
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-AV-133185 MBq | Drug | Alzheimer's Disease, Dementia with Lewy Bodies, Healthy Elderly Volunteers, Parkinson's disease |
| 18F-AV-45185-370 MBq | Drug | Alzheimer's Disease, Dementia with Lewy Bodies, Healthy Elderly Volunteers, Parkinson's disease |
Primary outcome
18F-AV-133 striatal to occipital standard uptake value ratio
Time frame: Four Weeks
The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region
1 secondary outcome
18F-AV-45 cortical to cerebellar standard uptake value ratio
Time frame: Four Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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Recruiting
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Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
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RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 18F-AV-133 and 18F-AV-45 in people with Dementia With Lewy Bodies and Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 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 15 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 14 Aug 2012. 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. 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
18F-AV-133 striatal to occipital standard uptake value ratio (time frame: Four Weeks). 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 14 Aug 2012.