RecruitingPhase 2NCT04840979

Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease

Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease With 11C-ER176


Sponsor

Columbia University

Enrollment

250 participants

Start Date

May 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objectives are to validate that a previously identified gene variant influences the proportion of activated microglia (PAM) and the amount of TSPO binding on PET imaging, to identify novel loci that influence PAM and TSPO PET, and to understand the functional consequences of gene variants that drive microglial activation in Alzheimer's disease.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for genetic factors that influence how immune cells in the brain (called microglia) become activated in Alzheimer's disease. Researchers want to understand why some people are more likely to develop brain inflammation linked to Alzheimer's. The study involves brain imaging and blood or spinal fluid tests — no experimental treatment is given. **You may be eligible if:** - You are 50 years or older - You have been diagnosed with mild cognitive impairment or Alzheimer's disease, OR you have no memory problems (healthy controls are also needed) - You have had a brain scan or spinal fluid test consistent with Alzheimer's changes (or negative, for controls) - You identify as White, non-Hispanic - You speak and read English fluently **You may NOT be eligible if:** - Your memory problems are caused by a condition other than Alzheimer's - You have had cancer in the past 5 years, severe epilepsy, or other serious brain conditions - You are unable to have an MRI or PET scan - You take blood thinners or immunosuppressive medication - You have a chronic inflammatory disease such as MS, lupus, or rheumatoid arthritis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG11C-ER176

11C-ER176 is a novel TSPO radioligand that was developed because of its relative insensitivity to the rs6971 polymorphism. Increased TSPO signal on PET is associated with activation of microglia in the brain. The radioligand will be administered in tracer doses at activity of up to 20 mCi (740 MBq), IV, total of one injection. A single dose of radioligand will be injected over 1 minute.

DRUG18F-florbetaben

Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. Florbetaben measures amyloid in the brain.


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT04840979


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