Cognitive ImpairmentNCT03981380
11C-PIB PET Study in MESA at Columbia University
An observational study of Cognitive Impairment and Vascular Diseases, run by José A. Luchsinger at 1 site in United States.
Trial summary
The investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Vascular Diseases, Alzheimer Disease
- What is being tested?
- 11C-PIB
- Type of treatment
- Injection or infusion
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 5 Feb 2024
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Current participants in MESA study in New York City
Who may be able to join
- Current participants in MESA study at Columbia University
- 60 years or older
- Fluent in English and/or Spanish.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
Who cannot join
- Active treatment for cancer
- Any serious medical condition which would prevent long-term participation
- Pregnancy
- Weight >300 pounds
- Participants previously diagnosed or adjudicated to have dementia
- Participants unwilling to undergo cognitive testing
Show all 9Show fewer
- Plans to leave the community within five years
- Language barrier (speaks other than English, Spanish, Chinese)
- Inability to give informed consent or to obtain consent from a Legally Authorized Representative (LAR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: 11C-PIB PET Study in the Multi Ethnic Study of Atherosclerosis at Columbia University
The investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Participants will be imaged only once with Pittsburgh Compound B (PIB) PET.
Read the detailed description
This is a single center PET study of 11C-PIB. Eligible participants are current participants in the MESA study in New York City, without contraindications to MRI or PET procedures. Those eligible will have one brain PET scan with 11C-PIB within 12 months of a brain MRI. Vital signs will be checked prior to injection of 11C-PIB, 10 minutes after the injection, and again at the completion of the PET scan. The primary outcome measure for amyloid will be whole brain 11C-PIB SUVR. The relation between exposure groups and amyloid in the brain will be analyzed using linear regression.
- Being tested
- 11C-PIB
- Keywords
- Alzheimer Disease, Cognitive Impairment, 11C-PiB, Atherosclerosis
- Medical subject headings
- Cognitive Dysfunction, Vascular Diseases, Alzheimer Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-PIBDrug
Also called PIB
Participants will be injected with an intravenous bolus of up to 5-15mCi (370 MBq) (+/-10%) of [11C]PiB (over 5-10 seconds).
| Study group | Role | What they receive |
|---|---|---|
| MESA study participants | Current participants in the MESA study in New York City, 60 years or older, fluent in English or Spanish, able to participate in the brain imaging study Receives: Drug: 11C-PIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Brain 11C-PIB SUVR
Standardized uptake value ratio (SUVR) of 11C-PIB;The extent of Aβ deposition in the brain will be quantified by[11C]PiB uptake visualized by PET using standardized uptake volume ratio (SUVR) of 6 primary cortical areas (i.e., anterior cingulate, prefrontal cortex, lateral temporal cortex, posterior parietal cortex, precuneus cortex, and anteroventral striatum) relative to the uptake in the cerebellum
Measured: 40 to 90 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Aug 2020
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- José A. Luchsinger
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, José A. Luchsinger, Columbia University
- Investigators
- José Luchsinger, MD, MPH, Principal investigator, Professor of Medicine and Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981380
- Sponsor's protocol ID
- AAAS2808
- Other IDs
- R01AG058969
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2019
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) may be shared at the end of data collection with a mechanism supported by the National Institute on Aging
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 11C-PIB PET Study in the Multi Ethnic Study of Atherosclerosis at Columbia University
- ClinicalTrials.gov ID
- NCT03981380
- Acronym / sponsor ID
- AAAS2808
- Keywords
- Alzheimer Disease, Cognitive Impairment, 11C-PiB, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- José A. LuchsingerUniversity, hospital or other
- Collaborators
- Wake Forest University, National Institute on Aging (NIA)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jun 2019 (actual)
- 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 investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Participants will be imaged only once with Pittsburgh Compound B (PIB) PET.
Detailed description
This is a single center PET study of 11C-PIB. Eligible participants are current participants in the MESA study in New York City, without contraindications to MRI or PET procedures. Those eligible will have one brain PET scan with 11C-PIB within 12 months of a brain MRI. Vital signs will be checked prior to injection of 11C-PIB, 10 minutes after the injection, and again at the completion of the PET scan. The primary outcome measure for amyloid will be whole brain 11C-PIB SUVR. The relation between exposure groups and amyloid in the brain will be analyzed using linear regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MESA study participants | – | Drug: 11C-PIBCurrent participants in the MESA study in New York City, 60 years or older, fluent in English or Spanish, able to participate in the brain imaging study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current participants in MESA study in New York City
Key inclusion criteria (4 listed)
- Current participants in MESA study at Columbia University
- 60 years or older
- Fluent in English and/or Spanish.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
Key exclusion criteria (9 listed)
- Active treatment for cancer
- Any serious medical condition which would prevent long-term participation
- Pregnancy
- Weight >300 pounds
- Participants previously diagnosed or adjudicated to have dementia
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 |
|---|---|---|
| 11C-PIBAlso: PIBParticipants will be injected with an intravenous bolus of up to 5-15mCi (370 MBq) (+/-10%) of [11C]PiB (over 5-10 seconds). | Drug | MESA study participants |
Primary outcome
Whole Brain 11C-PIB SUVR
Time frame: 40 to 90 minutes post injection
Standardized uptake value ratio (SUVR) of 11C-PIB;The extent of Aβ deposition in the brain will be quantified by[11C]PiB uptake visualized by PET using standardized uptake volume ratio (SUVR) of 6 primary cortical areas (i.e., anterior cingulate, prefrontal cortex, lateral temporal cortex, posterior parietal cortex, precuneus cortex, and anteroventral striatum) relative to the uptake in the cerebellum
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 18 Feb 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) may be shared at the end of data collection with a mechanism supported by the National Institute on Aging
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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.
José Luchsinger, MD, MPH principal investigator
Professor of Medicine and Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Vascular Diseases, run by José A. Luchsinger 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 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 Feb 2025. 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 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?
Whole Brain 11C-PIB SUVR (time frame: 40 to 90 minutes post 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 18 Feb 2025.