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NIH Awards $4.7M to Columbia University to study Chronic Lyme Disease

Dr. Brian Fallon of Columbia University has just received a $4.7 million grant from the National Institute of Neurological Disorders and Stroke to conduct a brain imaging and treatment study of adults with Lyme Disease who suffer from cognitive problems despite having had more than the standard prior IV antibiotic therapy. This award represents a major commitment by the National Institute of Health to understand better the chronic problems caused by Lyme Disease.

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This four-year study has two main parts: efficacy and brain imaging.

Efficacy. The efficacy component consists of a controlled trial of 10 weeks of IV Ceftriaxone (Rocephin) to determine whether a repeated course of therapy is helpful for patients with chronic persistent cognitive deficits. Two-thirds of the patients will receive IV antibiotic and one-third will receive IV placebo (ie, no antibiotic). (Patients who get IV placebo will have the option of getting 6 weeks of free IV medicine at the end of their 24 week participation in the study).

Brain Imaging. The brain imaging component is being conducted by one of the most advanced brain imaging teams in the country, directed by the Co-Principal Investigators' Dr. Harold Sackeim, Dr. Ronald Van Heertum, and Dr. Robert DeLaPaz. This team will be using the PET and MRI brain imaging facilities at the Columbia Presbyterian Medical Center to address many fundamental questions about the pathophysiology of Lyme Disease. Do patients with Lyme disease truly have a vasculitis - a finding that is often suggested by SPECT images of the brain? Are the bright spots seen on MRI scans areas of dead tissue - or - are they areas of low blood flow but struggling living nerve tissue? Do the brain imaging abnormalities correlate at all with the abnormalities in neuropsychological testing? What parts of the brain correlate with the memory problems or the attention problems? Do the brain imaging deficits improve at the same rate as the cognitive improvement? Is chronic Lyme encephalopathy primarily causing a nerve cell or a vascular problem? Each patient will get 3 sets of PET images: one looks at glucose metabolism, one at blood flow, and one at blood flow after a carbon dioxide challenge. Why a carbon dioxide challenge? A slight increase in the amount of carbon dioxide in the atmosphere tells the brain's blood vessels to dilate. Healthy blood vessels will dilate in a symmetric diffuse manner. Unhealthy vessels will not dilate as much, revealing areas on the PET scan of decreased perfusion in response to a hypercapnic challenge. In addition, patients will get 5 different sequences of MRI imaging to look at the structure of the brain, extensive blood tests, and cognitive testing. All of these tests will be repeated 2 weeks after completing the 10 weeks of antibiotics and then again 14 weeks after finishing the IV therapy. The week 12 tests will look for response. The week 24 tests will look to see if the response improves over time, stays the same, or worsens.

Implication. This study is sorely needed. Doctors need to know whether repeated therapy is truly helpful. If it is helpful, this will be demonstrated in a scientific way so that everyone (including the skeptics) will believe the results. The Columbia group will try to identify markers at baseline that might be associated with either a good response or a poor response to repeated antibiotic therapy. For example, does evidence of vascular brain disease point to patients who may not respond? Do patients who have had shorter course of prior therapy do better than those with longer courses? Are there blood test markers (such as Babesia coinfection) that might be associated with poorer response? Are there CSF markers that might provide clues to response?

Who is eligible to participate in this study? Adults who meet the major criteria list below may be eligible for the study:
    • Age 18-60 with a history of well-documented Lyme Disease
    • Persistent cognitive problems despite having received at least 8 weeks of IV antibiotic therapy at some point in the past
    • CSF or blood tests that currently are Western Blot IgG positive or PCR positive
    • Willingness to participate in a study in which there is a 2 of 3 chance of getting IV antibiotic and a 1 of 3 chance of getting IV placebo.
    • Residence in New York State, Connecticut, New Jersey, and some sections of Pennsylvania. The study is limited to these areas because of the restricted geographic area of the home infusion company that sends nurse to the patients' homes to provide the home antibiotic therapy.

People interested in learning more about how to participate in this free study should contact the Lyme Disease Research Program at 212-543-5367. Please leave your name and phone number and someone will call you back promptly. If you wish to reach the study coordinator, please call 212-543-6508.

Why should patients participate in this study?
    • First, all patients will get treated with IV antibiotic free of charge at some point. One group (2/3 of the patients) will get 10 weeks right away, the other group (1/3 of the patients) will get offered 6 weeks of free IV antibiotic after the 24 weeks.
    • Second, all patients will get a report at the end of the 24 weeks summarizing the results of the sophisticated MRI, PET, and cognitive test results. This cognitive report will provide a breakdown of the different cognitive domains of the brain and show how the patient did over the 24 week period on each domain (e.g., attention, memory, verbal fluency). The brain imaging report will reveal whether the patient had a normal enhancement of flow after the CO2 challenge -- the "hypercapnic" challenge test can detect the presence of vascular disease -- and whether that deficit (if present) improved over the 24 weeks or not. The science of this study is quite fine and should provide very valuable information about how Lyme Disease affects the brain.
    • Finally, in addition to the personal benefits resulting from participation, Dr. Fallon hopes that patients will want to participate because they are interested in promoting good scientific research of chronic Lyme disease. If this study is not able to attract enough patients, then he suspects that NIH will be highly reluctant to ever again risk funding a major chronic Lyme disease study.

Dr. Fallon notes that the criteria for entry in the study are very strict. He cautions that he is not stating that patients who are "ineligible" do not have Lyme Disease. Rather, the study requires that patients who enter would be only those patients who everyone would agree have Lyme disease. Why? Mainly because the study procedures are so very expensive. The Columbia team and the National Institutes of Health wish to make sure that in four years the results of this study (whatever they are) will be believed by everyone.

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