Patients needed for Dr Fallon's new Chronic LD study

[Guest guest]

LDA-NJ has worked with Dr Fallon for many years & is pleased to

publicize his newest efforts.

NIH Awards $4.7 Million to Columbia University to study Chronic Lyme

Disease.

Dr. 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.

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. Van Heertum,

and Dr. 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 212-543-6508.

Please leave your name and phone number and someone will call you back

promptly. If you wish to reach Dr. Fallon directly, please call

212-543-5487.

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.