Alzheimer's DiseasePhase 4NCT00950430
Imaging of Brain Amyloid Plaques in the Aging Population
A Phase 4 study testing Pittsburgh Compound B (C-11 PiB), F-18 FDG and Tau (18-F-AV-1451) in people with Alzheimer's Disease and Dementia With Lewy Bodies, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia With Lewy Bodies, Frontotemporal Dementia
- What is being tested?
- Pittsburgh Compound B (C-11 PiB), F-18 FDG and Tau (18-F-AV-1451)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-100
- Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.
Who cannot join
- Subjects unable to lie down without moving for 10 minutes
- Women who are pregnant or cannot stop breast feeding for 24 hours at the time of scanning
- Claustrophobic patients unable to tolerate the scans
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia
This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.
Read the detailed description
Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.
- Conditions
- Alzheimer's Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Vascular Dementia
- Being tested
- Pittsburgh Compound B (C-11 PiB), F-18 FDG, Tau (18-F-AV-1451)
- Keywords
- Imaging, PET, PiB, FDG, MCI, Dementia, Alzheimer's Disease, Brain Amyloid
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia, Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh Compound B (C-11 PiB)Drug
Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
F-18 FDGDrug
Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
Tau (18-F-AV-1451)Drug
- PIB PET scan, Tau PET scan and/or FDG PET scan
- Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. ECG will be performed on subjects who have not had previous ECG test at Mayo to rule out prolonged QT interval prior to PET TAU scan.
| Study group | Role | What they receive |
|---|---|---|
| PiB PET, FDG PET, Tau PET | Experimental | Not described Receives: Drug: Pittsburgh Compound B (C-11 PiB); Drug: F-18 FDG; Drug: Tau (18-F-AV-1451) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
Measured: up to 20 years
Secondary outcomes (4)
Using PiB-PET, to ascertain cross-sectionally the magnitude and the spatial distribution of amyloid deposition in the brain in subjects who are clinically classified as CN, MCI, and demented.
Measured: up to 20 years
To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.
Measured: up to 20 years
To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.
Measured: up to 20 years
To measure longitudinal change in amyloid burden and cognition and characterize the correlation between change on serial PiB-PET measures vs. FDG measures and concurrent change on continuous measures of cognitive performance.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Val Lowe, Mayo Clinic
- Investigators
- Val Lowe, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950430
- Sponsor's protocol ID
- 08-005553
- Other IDs
- U01AG006786, R01AG011378
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2009
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia
- ClinicalTrials.gov ID
- NCT00950430
- Acronym / sponsor ID
- 08-005553
- Conditions
- Alzheimer's Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Vascular Dementia
- Keywords
- Imaging, PET, PiB, FDG, MCI, Dementia, Alzheimer's Disease, Brain Amyloid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2008
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jul 2009 (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.
This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.
Detailed description
Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PiB PET, FDG PET, Tau PET | Experimental | Drug: Pittsburgh Compound B (C-11 PiB), Drug: F-18 FDG, Drug: Tau (18-F-AV-1451) |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 30-100
- Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.
Key exclusion criteria (4 listed)
- Subjects unable to lie down without moving for 10 minutes
- Women who are pregnant or cannot stop breast feeding for 24 hours at the time of scanning
- Claustrophobic patients unable to tolerate the scans
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
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 |
|---|---|---|
| Pittsburgh Compound B (C-11 PiB)Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. | Drug | PiB PET, FDG PET, Tau PET |
| F-18 FDGRepeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. | Drug | PiB PET, FDG PET, Tau PET |
| Tau (18-F-AV-1451)1. PIB PET scan, Tau PET scan and/or FDG PET scan 2. Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. ECG will be performed on subjects who have not had previous ECG test at Mayo to rule out prolonged QT interval prior to PET TAU scan. | Drug | PiB PET, FDG PET, Tau PET |
Primary outcome
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
Time frame: up to 20 years
4 secondary outcomes
Using PiB-PET, to ascertain cross-sectionally the magnitude and the spatial distribution of amyloid deposition in the brain in subjects who are clinically classified as CN, MCI, and demented.
Time frame: up to 20 years
To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.
Time frame: up to 20 years
To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.
Time frame: up to 20 years
To measure longitudinal change in amyloid burden and cognition and characterize the correlation between change on serial PiB-PET measures vs. FDG measures and concurrent change on continuous measures of cognitive performance.
Time frame: up to 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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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.
Val Lowe, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pittsburgh Compound B (C-11 PiB), F-18 FDG and Tau (18-F-AV-1451) in people with Alzheimer's Disease and Dementia With Lewy Bodies, run by Mayo Clinic 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 23 Jun 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 understand the predictive ability of PiB PET imaging for neurodegenerative diseases. (time frame: up to 20 years). 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 23 Jun 2026.