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Title: Information Regarding the Columbia Persistent Lyme Encephalopathy Study
Entered By: Ira M Maurer/LymeNetDate Created: 02/21/2000

Internet URL:


THIS INFORMATION IS FOR DOCTORS REFERRING PATIENTS TO THE COLUMBIA PERSISTENT LYME ENCEPHALOPATHY STUDY (DR. FALLON'S FEDERALLY FUNDED STUDY)

WHO IS ELIGIBLE?

Age: 18-60

Lyme History: Well-documented history of either:
a. erythema migrans; or
b. at least one of the CDC clinical features of Lyme disease
and a reactive IgG or IgM Western blot historically

Current Lyme Status: Reactive IgG Western blot or a positive PCR
Current cognitive problems

Prior Lyme Treatment: Patients must have completed a total of at least 8 weeks of IV
antibiotics previously (e.g., at least two 4-week trials or
one 8 week trial or more).
What is the Study?

Sixty patients with previously treated persistent Lyme encephalopathy will be randomly assigned to receive 10 weeks of IV antibiotic or 10 weeks of IV placebo. While 2 of 3 patients will get IV antibiotic during the double-blind phase, 1 of 3 patients will be given IV placebo. Patients given IV placebo during the double-blind phase will have the option of getting 6 weeks of IV antibiotic at no cost at the end of the study. Patients will be evaluated in several ways at three major points (baseline, week 12, and week 24): brain imaging (MRI and PET using 3 different types); neuropsychological testing; clinical exam; blood and CSF tests. From week 10-24, patients will be off antibiotics so that we can determine whether they improve further, stay the same, or relapse. after week 24, patients are free to pursue any other treatment they wish.

What are the three goals of the study?

1.Brain Imaging. To understand better the pathophysiologic basis of Lyme encephalopathy. In particular, is LE caused by a
Lyme- induced small vessel vasculitis or a nerve cell metabolism problem? Do the brain imaging deficits
correlate with cognitive deficits or CSF abnormalities? Do the brain imaging deficits improve with time or
remain static?

2. Treatment. To determine whether 10 weeks of IV antibiotics are beneficial for patients with persistent symptoms who
have already received abundant treatment.

3. Prognostic Factors. To determine whether there are features at baseline that might be associated with response (e.g.,
amount of prior treatment; CSF abnormalities; level of CSF matrix metalloproteinase; presence of immune
complexes; ability of the brain vasculature to dilate normally to a carbon-dioxide challenge.

What does the study mean to the patient?

1. The patient will get state-of-the-art brain testing using MRI, PET, and neuropsychological testing. A report will be
generated at the end of the patient's participation in the study summarizing some of the key findings. The
testing and the treatment costs along for each patient amount to over $25,000.

2. The patient will need to come to Columbia for the testing and imaging. The treatments however will be done at the
patient's home via a home infusion company.

What does the study mean to the referring doctor?

1. We ask you to see your patient at various intervals during the study in order to provide a hands-on assessment and to be
available for any emergencies should they arise. While in the study, you cannot provide any antibiotics as that would
confuse the results of our study and make your patient ineligible to continue in the study. Our grant has funds to
compensate you for patient visits. You agree to write a brief note summarizing every patient visit and fax it back to us. You
therefore become an integral part of the patient's treatment team during the study.

This is a 4 year NIH-funded study extending from Dec 1999 to Nov 2003. Dr. Fallon is now screening patients. Only patients who live within commuting distance of NYC (NJ, CT, NY, Delaware, areas of PA near NJ ) or who have a relative with whom they could live in the tri-state area during the treatment phase are eligible. The reason for this is that the home infusion company being used in the study has a limited range and patient safety could be compromised if the patients live beyond the designated inclusion area.

How do I refer a patient to the study? Ask the patient to call Dr. Fallon at 212-543-5487


The Lyme Disease Network of NJ, Inc.
43 Winton Road
East Brunswick, NJ 08816
http://www.lymenet.org/