DementiaNCT02343757
Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
A study testing PET/MRI in people with Dementia and Alzheimer Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- PET/MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 9 Nov 2016
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition,
- Patients equal to or greater than 21 years old,
- Signed informed consent by patient or legal guardian,
- Physically capable to cooperate.
Who cannot join
- Subjects who do not meet the above mentioned inclusion criteria,
- Subjects unwilling or unable to sign the informed consent form,
- Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study,
- Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices),
- History of adverse events related to a previous MR or PET/CT,
- Pregnant women,
- Minors.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital Case Medical Center
Cleveland, Ohio, 44106
About this study
The early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their strengths in one machine.
Specific Aims and Hypotheses can be summarized as follows:
- To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
- To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
- To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- PET/MRI
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| PET/CT vs. PET/MRI | Other | Patients will be included if presenting with the clinical suspicious of AD, Mild Cognitive Impairment (MCI) or other cognitive impairment to be further determined.
Patients will undergo two doubles scans in two steps with a maximum of 2 week between both: the first step will be one day double scan with FDG imaged by PET-CT and PET-MRI; and the second step will be one day double scan with 18F-florbetapir imaged by PET-CT and PET-MRI at a different timepoints as shown in figure 1. Receives: Device: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
Measured: within one year
Secondary outcomes (2)
To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone.
- To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
Measured: within one year
To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application;
- To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid (Philips Research, Hamburg)
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startOct 2013
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
Why it stopped: Not enough patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James K O'Donnell, MD, Principal investigator, Unviversity Hospitals Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343757
- Sponsor's protocol ID
- 12-12-13
- Status last verified
- May 2022
- First submitted
- 8 May 2014
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
- ClinicalTrials.gov ID
- NCT02343757
- Acronym / sponsor ID
- 12-12-13
- Conditions
- Dementia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patient enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 22 Jan 2015 (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 early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their strengths in one machine.
Specific Aims and Hypotheses can be summarized as follows:
- To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
- To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
- To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT vs. PET/MRI | Other | Device: PET/MRIPatients will be included if presenting with the clinical suspicious of AD, Mild Cognitive Impairment (MCI) or other cognitive impairment to be further determined. Patients will undergo two doubles scans in two steps with a maximum of 2 week between both: the first step will be one day double scan with FDG imaged by PET-CT and PET-MRI; and the second step will be one day double scan with 18F-florbetapir imaged by PET-CT and PET-MRI at a different timepoints as shown in figure 1. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition,
- Patients equal to or greater than 21 years old,
- Signed informed consent by patient or legal guardian,
- Physically capable to cooperate.
Key exclusion criteria (7 listed)
- Subjects who do not meet the above mentioned inclusion criteria,
- Subjects unwilling or unable to sign the informed consent form,
- Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study,
- Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices),
- History of adverse events related to a previous MR or PET/CT,
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 |
|---|---|---|
| PET/MRI | Device | PET/CT vs. PET/MRI |
Primary outcome
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
Time frame: within one year
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
2 secondary outcomes
To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone.
Time frame: within one year
To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application;
Time frame: within one year
Results and safety
The study was stopped early (reason given: Not enough patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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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.
James K O'Donnell, MD principal investigator
Unviversity Hospitals Case Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Dementia and Alzheimer Disease, run by University Hospitals Cleveland Medical Center 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 May 2022. 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.
Are results available for this study?
The study was stopped early (reason given: Not enough patient enrollment). Results are not available in the source record.
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?
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients. (time frame: within one year). 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 12 May 2022.