A Phase 2 interventional study of 11C-ER176 and 18F-MK6240 in Alzheimer Disease, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Columbia University · Phase 2, Interventional, and Diagnostic
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:
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
* 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
Drug: 11C-ER176 · Drug: 18F-MK6240 · Drug: 18F-Florbetaben · Procedure: Lumbar Puncture
Healthy controls
Drug: 11C-ER176 · Drug: 18F-MK6240 · Drug: 18F-Florbetaben · Procedure: Lumbar Puncture
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.
Also known as: [11C] ER176
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.
Also known as: [18F-MK6240]
Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain.
Also known as: [18F] Florbetaben
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).
Also known as: Spinal Tap
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).
Time frame: 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).
Time frame: Up to 24 months
Plan to share: Yes — Individual participant data will be available upon reasonable request from a qualified investigator.
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