Alzheimer DiseasePhase 1/2NCT03744312
Imaging Inflammation in Alzheimer's Disease With 11C-ER176
A Phase 1/2 study testing 11C-ER176 and Florbetaben in people with Alzheimer Disease, run by Columbia University at 1 site in United States.
Trial summary
This study is being done to learn about inflammation in the brain of those with Alzheimer's disease (AD). The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. 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?
- 11C-ER176 and Florbetaben
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 20 Jul 2022
- Phase
- Phase 1/2
- 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
- Age 50 and older
- Meet criteria for either a) amnestic mild cognitive impairment or Alzheimer's disease, or b) have no cognitive impairment
- If you are unable to provide informed consent, you must have a surrogate decision maker and be able to verbally assent to the study procedures
- Written and oral fluency in English
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the investigator, you must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Who cannot join
- Past or present history of certain brain disorders other than MCI or AD.
- Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
- Contraindication to MRI scanning
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place you above the allowable limits.
- Participation in the last year in a clinical trial for a disease modifying drug for AD.
Show all 9Show fewer
- Inability to have a catheter in your vein for the injection of radioligand.
- Inability to have blood drawn from your veins.
- Taking anticoagulant medication (e.g., warfarin).
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
This study is being done to learn about inflammation in the brain of those with Alzheimer's disease (AD). The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Both patients (with either mild cognitive impairment (MCI) or Alzheimer's disease) and healthy controls (participants without memory complaints or impairment) will be included in this study.
Read the detailed description
Inflammation likely plays a role in the damage to the brain caused by Alzheimer's disease.
Accurately measuring inflammation in the brain could provide new information about the mechanisms that cause Alzheimer's disease, and could help identify new treatments that reduce inflammation. Positron emission tomography (PET) imaging is a type of brain scanning method that allows investigators to measure small molecules in the brain. ER176-PET was recently developed as an improved method for measuring brain inflammation. However, ER176-PET has not yet been used in patients with Alzheimer's disease. The investigators propose to use ER176-PET imaging in subjects with mild cognitive impairment (a very early stage of Alzheimer's disease) or mild Alzheimer's disease to compare the amount of inflammation with that seen in older control subjects. The investigators will first use a "gold standard" method of measuring ER176 in brain that requires sampling arterial blood during the scan. The investigators will compare these results to those obtained using novel methods that don't require blood sampling. The investigators hope to show that ER176 is a useful tool for measuring inflammation in Alzheimer's disease, and that the investigators can develop a way to obtain ER176 PET scans that don't require arterial blood sampling.
This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special dye is injected into the body. Two types of dye will be used in this study: Florbetaben and 11C-ER176. Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. Florbetaben has been approved by the Food and Drug Administration to help diagnose Alzheimer's disease. 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- 11C-ER176, Florbetaben
- Keywords
- Inflammation, PET scans
- Medical subject headings
- Alzheimer Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-ER176Drug
Also called [11C] ER176
11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
FlorbetabenDrug
Also called NeuraCeq
Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive impairment | Experimental | Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia) Receives: Drug: 11C-ER176; Drug: Florbetaben |
| No cognitive impairment | Active comparator | Healthy Controls Receives: Drug: 11C-ER176; Drug: Florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-ER176 Total Distribution Volume
Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling.
Measured: Up to one year from baseline
Secondary outcomes (1)
11C-ER176 Standardized Uptake Value Ratio
The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 positron emission tomography (PET) scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). This is a simplified quantification technique compared to the Total Distribution Volume, but is linearly related to it. Higher values indicate more neuroinflammation.
Measured: Up to one year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start10 Sep 2018
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
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.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Lao, Columbia University
- Investigators
- Patrick Lao, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744312
- Sponsor's protocol ID
- AAAR6570
- Status last verified
- Apr 2025
- First submitted
- 14 Nov 2018
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available upon reasonable request from a qualified investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Inflammation in Alzheimer's Disease With 11C-ER176
- ClinicalTrials.gov ID
- NCT03744312
- Acronym / sponsor ID
- AAAR6570
- Conditions
- Alzheimer Disease
- Keywords
- Inflammation, PET scans
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn about inflammation in the brain of those with Alzheimer's disease (AD). The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Both patients (with either mild cognitive impairment (MCI) or Alzheimer's disease) and healthy controls (participants without memory complaints or impairment) will be included in this study.
Detailed description
Inflammation likely plays a role in the damage to the brain caused by Alzheimer's disease.
Accurately measuring inflammation in the brain could provide new information about the mechanisms that cause Alzheimer's disease, and could help identify new treatments that reduce inflammation. Positron emission tomography (PET) imaging is a type of brain scanning method that allows investigators to measure small molecules in the brain. ER176-PET was recently developed as an improved method for measuring brain inflammation. However, ER176-PET has not yet been used in patients with Alzheimer's disease. The investigators propose to use ER176-PET imaging in subjects with mild cognitive impairment (a very early stage of Alzheimer's disease) or mild Alzheimer's disease to compare the amount of inflammation with that seen in older control subjects. The investigators will first use a "gold standard" method of measuring ER176 in brain that requires sampling arterial blood during the scan. The investigators will compare these results to those obtained using novel methods that don't require blood sampling. The investigators hope to show that ER176 is a useful tool for measuring inflammation in Alzheimer's disease, and that the investigators can develop a way to obtain ER176 PET scans that don't require arterial blood sampling.
This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special dye is injected into the body. Two types of dye will be used in this study: Florbetaben and 11C-ER176. Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. Florbetaben has been approved by the Food and Drug Administration to help diagnose Alzheimer's disease. 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive impairment | Experimental | Drug: 11C-ER176, Drug: FlorbetabenAlzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia) |
| No cognitive impairment | Active comparator | Drug: 11C-ER176, Drug: FlorbetabenHealthy Controls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 and older
- Meet criteria for either a) amnestic mild cognitive impairment or Alzheimer's disease, or b) have no cognitive impairment
- If you are unable to provide informed consent, you must have a surrogate decision maker and be able to verbally assent to the study procedures
- Written and oral fluency in English
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
Key exclusion criteria (9 listed)
- Past or present history of certain brain disorders other than MCI or AD.
- Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
- Contraindication to MRI scanning
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place you above the allowable limits.
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-ER176Also: [11C] ER17611C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. | Drug | Cognitive impairment, No cognitive impairment |
| FlorbetabenAlso: NeuraCeqFlorbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. | Drug | Cognitive impairment, No cognitive impairment |
Primary outcome
11C-ER176 Total Distribution Volume
Time frame: Up to one year from baseline
Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling.
1 secondary outcome
11C-ER176 Standardized Uptake Value Ratio
Time frame: Up to one year from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data will be available upon reasonable request from a qualified investigator.
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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.
Patrick Lao, PhD principal investigator
Columbia University
1 site 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 11C-ER176 and Florbetaben in people with Alzheimer Disease, run by Columbia University 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 6 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 17 Apr 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.
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?
Yes. Results are posted in the registry (first posted 13 Sep 2023). 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?
11C-ER176 Total Distribution Volume (time frame: Up to one year from baseline). 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 17 Apr 2025.