Alzheimer DiseasePhase 2ADVISeNCT04576793
Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
A Phase 2 study testing 11C-ER176, 18F-MK6240 and 18F-Florbetaben in people with Alzheimer Disease, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). 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, 18F-MK6240 and 18F-Florbetaben
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 31 May 2027
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 and over at time of screening.
- At screening, must have no cognitive impairment, or meet criteria for amnestic Alzheimer's disease, posterior cortical atrophy, or logopenic variant primary progressive aphasia. Diagnoses will be made based on history, exam, neuropsychological testing, brain MRI, and consensus diagnosis.
- Patients must have Clinical Dementia Rating scale score of 0.5 or 1 at enrollment. Controls must have Clinical Dementia Rating scale score of 0 at enrollment.
- Subjects unable to provide informed consent must have a surrogate decision maker.
- Written and oral fluency in English or Spanish.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the PI, the subject 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 a brain disorder other than Alzheimer's disease (including presence of cortical infarct on MRI even in absence of clinical stroke).
- Serious 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 subjects above the allowable limits.
- Exact medication exclusions are up to the discretion of the PI in consultation with the MD liaison.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Diana S. Guzman, 212-305-9079, dsg2158@cumc.columbia.edu
About this study
The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with:
- Mild Cognitive Impairment
- Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties
- Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties
- Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties
- The investigators are also enrolling older adults with normal visual, language, and memory function.
Read the detailed description
This study is being done to learn about inflammation in Alzheimer's disease so that the investigators can find out new ways to treat patients with this disease. Because Alzheimer's disease usually causes slow changes to the brain over time, in this study the investigators are going to perform different tests and then repeat some of them two years later.
Inflammation can be measured using a type of brain scan called a positron emission tomography (PET) scan. A PET scan uses very small amounts of a radioactive drug that is injected into a vein to create a special picture of the brain. The inflammation PET scan uses a drug called ER176. ER176 is an experimental drug but has been used in several human studies before. Once in the body, ER176 sticks to areas with lots of inflammation, and the PET scan allows us to see these areas.
Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators need to perform a lumbar puncture (spinal tap). Certain genes that inherited from parents influence the amount of inflammation in the body. The investigators can study how genes affect inflammation in Alzheimer's disease by looking doing genetic tests on blood that collected from the vein.
The investigators can study how genes affect inflammation in Alzheimer's disease by doing genetic tests on blood. The investigators will also be testing blood for severe acute respiratory syndrome (SARS)- CoV-2 (the virus that causes COVID-19) antibodies. The investigators want to see if exposure to the virus that causes COVID-19 changes the amount of inflammation in the brain or not.
Along with inflammation, Alzheimer's disease is also associated with the build up of the proteins amyloid and tau in the brain. The investigators can measure these proteins using PET scans. The amyloid PET scan uses a drug called florbetaben that has been approved by the FDA to help diagnose Alzheimer's disease. The tau PET scan uses a drug called MK-6240. Like ER176, MK-6240 is experimental but has been used in several human studies before.
A brain MRI creates a high resolution picture of the brain. The brain MRI helps the investigators get more information from the PET scans, and can also tell the investigators the size and appearance of different brain structures. When someone has Alzheimer's disease, some of these brain structures get smaller or have altered appearance on MRI.
- Conditions
- Alzheimer Disease
- Being tested
- 11C-ER176, 18F-MK6240, 18F-Florbetaben, Lumbar Puncture
- Keywords
- Inflammation, PET scans, Cognitive Impairment, Posterior Cortical Atrophy, Logopenic Variant Primary Progressive Aphasia, Amnestic Alzheimer's Disease, MK-6240, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Inflammation, Cognitive Dysfunction
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. 11C-ER176 will be administered at activity up to 20 millicurie (mCi) per injection.
18F-MK6240Drug
Also called [18F-MK6240]
MK-6240 measures a protein called in the brain. MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.
18F-FlorbetabenDrug
Also called [18F] Florbetaben
Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain.
Lumbar PunctureProcedure or surgery
Also called Spinal Tap
Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators will perform a lumbar puncture (spinal tap).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive impairment | Experimental | * Mild Cognitive Impairment
* Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties
* Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties
* Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties Receives: Drug: 11C-ER176; Drug: 18F-MK6240; Drug: 18F-Florbetaben; Procedure: Lumbar Puncture |
| No cognitive impairment | Active comparator | Healthy controls Receives: Drug: 11C-ER176; Drug: 18F-MK6240; Drug: 18F-Florbetaben; Procedure: Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-ER176 Standardized Uptake Value Ratio
The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
Measured: Up to 24 months
18F-MK6240 Standardized Uptake Value Ratio
The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-MK6240 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start17 Nov 2020
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Patrick Lao, Columbia University
- Investigators
- Patrick J. Lao, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576793
- Sponsor's protocol ID
- AAAS7810
- Other IDs
- R01AG063888
- Acronym
- ADVISe
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04576793
- Acronym / sponsor ID
- ADVISe / AAAS7810
- Conditions
- Alzheimer Disease
- Keywords
- Inflammation, PET scans, Cognitive Impairment, Posterior Cortical Atrophy, Logopenic Variant Primary Progressive Aphasia, Amnestic Alzheimer's Disease, MK-6240, Mild Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Oct 2020 (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 purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with:
- Mild Cognitive Impairment
- Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties
- Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties
- Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties
- The investigators are also enrolling older adults with normal visual, language, and memory function.
Detailed description
This study is being done to learn about inflammation in Alzheimer's disease so that the investigators can find out new ways to treat patients with this disease. Because Alzheimer's disease usually causes slow changes to the brain over time, in this study the investigators are going to perform different tests and then repeat some of them two years later.
Inflammation can be measured using a type of brain scan called a positron emission tomography (PET) scan. A PET scan uses very small amounts of a radioactive drug that is injected into a vein to create a special picture of the brain. The inflammation PET scan uses a drug called ER176. ER176 is an experimental drug but has been used in several human studies before. Once in the body, ER176 sticks to areas with lots of inflammation, and the PET scan allows us to see these areas.
Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators need to perform a lumbar puncture (spinal tap). Certain genes that inherited from parents influence the amount of inflammation in the body. The investigators can study how genes affect inflammation in Alzheimer's disease by looking doing genetic tests on blood that collected from the vein.
The investigators can study how genes affect inflammation in Alzheimer's disease by doing genetic tests on blood. The investigators will also be testing blood for severe acute respiratory syndrome (SARS)- CoV-2 (the virus that causes COVID-19) antibodies. The investigators want to see if exposure to the virus that causes COVID-19 changes the amount of inflammation in the brain or not.
Along with inflammation, Alzheimer's disease is also associated with the build up of the proteins amyloid and tau in the brain. The investigators can measure these proteins using PET scans. The amyloid PET scan uses a drug called florbetaben that has been approved by the FDA to help diagnose Alzheimer's disease. The tau PET scan uses a drug called MK-6240. Like ER176, MK-6240 is experimental but has been used in several human studies before.
A brain MRI creates a high resolution picture of the brain. The brain MRI helps the investigators get more information from the PET scans, and can also tell the investigators the size and appearance of different brain structures. When someone has Alzheimer's disease, some of these brain structures get smaller or have altered appearance on MRI.
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: 18F-MK6240, Drug: 18F-Florbetaben, Procedure: Lumbar Puncture* Mild Cognitive Impairment * Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties * Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties * Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties |
| No cognitive impairment | Active comparator | Drug: 11C-ER176, Drug: 18F-MK6240, Drug: 18F-Florbetaben, Procedure: Lumbar PunctureHealthy controls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 50 and over at time of screening.
- At screening, must have no cognitive impairment, or meet criteria for amnestic Alzheimer's disease, posterior cortical atrophy, or logopenic variant primary progressive aphasia. Diagnoses will be made based on history, exam, neuropsychological testing, brain MRI, and consensus diagnosis.
- Patients must have Clinical Dementia Rating scale score of 0.5 or 1 at enrollment. Controls must have Clinical Dementia Rating scale score of 0 at enrollment.
- Subjects unable to provide informed consent must have a surrogate decision maker.
- Written and oral fluency in English or Spanish.
Key exclusion criteria (6 listed)
- Past or present history of a brain disorder other than Alzheimer's disease (including presence of cortical infarct on MRI even in absence of clinical stroke).
- Serious 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 subjects 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. 11C-ER176 will be administered at activity up to 20 millicurie (mCi) per injection. | Drug | Cognitive impairment, No cognitive impairment |
| 18F-MK6240Also: [18F-MK6240]MK-6240 measures a protein called in the brain. MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain. | Drug | Cognitive impairment, No cognitive impairment |
| 18F-FlorbetabenAlso: [18F] FlorbetabenFlorbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain. | Drug | Cognitive impairment, No cognitive impairment |
| Lumbar PunctureAlso: Spinal TapInflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators will perform a lumbar puncture (spinal tap). | Procedure or surgery | Cognitive impairment, No cognitive impairment |
Primary outcome
11C-ER176 Standardized Uptake Value Ratio
Time frame: Up to 24 months
The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
18F-MK6240 Standardized Uptake Value Ratio
Time frame: Up to 24 months
The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-MK6240 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).
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 6 Jul 2026.
- 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.
Patrick J. 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 2 study testing 11C-ER176, 18F-MK6240 and 18F-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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jul 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 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?
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?
Contact Diana S. Guzman (212-305-9079, dsg2158@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11C-ER176 Standardized Uptake Value Ratio (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 6 Jul 2026.