Re: Controlled trial ABX persistant lyme

From: A_Weisman (a_weisman_at_yahoo.com)
Date: 07/09/04 

Date: 9 Jul 2004 01:34:53 -0700

GregGerber@hotmail.com (Greg Gerber) wrote in message news:<146041df.0407061520.365c2854@posting.google.com>...
> derdrittemann2003@yahoo.com (derdrittemann) wrote in message news:<f2af2263.0407051830.87a0164@posting.google.com>...
>
> > I am certainly NOT a supporter or defender of that study...but what
> > was used was a Rocephin iv and followed up with oral doxycycline...as
> > indicated by the ISDA guidelines...
> >
> > ...what part of that regimen do you think is "useless"?
>
> 1. The dose of doxy was insufficient for CNS penetration no matter
> what length of therapy:
> Dotevall L, Hagberg L. Penetration of doxycycline into cerebrospinal
> fluid in patients treated for suspected Lyme neuroborreliosis.
> Antimicrob Agents Chemother 1989;33:1078?80.
>
> 2. The study was a retreatment study, in which patients were treated
> with the same therapies they had already failed; it was NOT a long
> term study as the treatment in the study was not long term, by any
> real-world standard.
>
> 3. The majority of patients entered in the study failed early
> treatment, and thus are in a different group than most chronic
> patients, who never got early treatment. The HLA marker found in these
> patients indicates they may indeed have had an under-the-radar immune
> dysfunction --but since they fall into the relatively small group that
> fails early treatment, they do not represent a model for the majority
> of chronic patients (who mostly lack the HLA marker but never got
> early treatment.)
>
> 4. the study did not adequately define "chronic Lyme disease," and
> thus, studied a broad group (in terms of symptoms, signs and
> presentation)
>
> It was an outrageously sloppy study.
>
> GG

Greg, der dritte mann, rita:

Let's talk about the Fallon Study. In advance. I'm NOT recommending
it. I think Fallon's a good guy. I don't think this study is going to
be a good thing for Lymeland.

Greatcod feel free to weigh in here with your concerns about humanity
science and medicine.

Bob we'd love to hear from you too. And anyone else with something to
add.

Sufein give us a dose of your sunny disposition too. :-) Every thread
needs your breath of foul air to make it Lymish.
 
 Clinical Trial: Brain Imaging and Retreatment Study of Persistent
Lyme Disease
http://www.clinicaltrials.gov/ct/show/NCT00037479?order=1

Brain Imaging and Retreatment Study of Persistent Lyme DiseaseThis
study is currently recruiting patients.Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
http://www.ninds.nih.gov/

 Purpose The purpose of this study is to determine whether patients
with persistent memory problems after Lyme disease benefit from an
additional longer course of IV antibiotic therapy; to use modern brain
imaging technology to determine whether the problem in the central
nervous system is primarily one of poor blood flow or one of impaired
nerve cell functioning; and to try to identify biological markers
prior to treatment that will identify patients who are more or less
likely to respond to the study treatment.

Condition Treatment or Intervention Phase
Lyme Disease
Lyme Neuroborreliosis

Drug: ceftriaxone
Phase II
http://www.clinicaltrials.gov/ct/info/phase;jsessionid=03D9E265E4EFC79EEF42CF7A74051D56

MedlinePlus related topics:  Bacterial Infections;   Lyme Disease;  
Neurologic Diseases

Study Type: Interventional

Study Design: Treatment, Randomized, Placebo Control Official Title:
PET and MRI Imaging of Persistent Lyme EncephalopathyFurther Study
Details: Some people with a history of Lyme disease continue to have
problems despite having received "textbook duration" antibiotic
therapy. When memory, attention, or thinking problems persist, the
syndrome is called persistent Lyme disease (PLD). This study seeks to
answer critical scientific questions about the treatment and cause of
PLD symptoms. This 24-week treatment study will evaluate each
patient's response to treatment using neuropsychological testing and
state-of-the-art brain imaging. The brain tests include
neuropsychological testing of memory and attention, brain imaging (MRI
and PET scans) to look at blood flow in the brain and nerve cell
structure and metabolism, a neurological exam, and studies of the
fluid that surrounds the brain (cerebrospinal fluid). The treatment
involves 10 weeks of either intravenous antibiotic called ceftriaxone
(also known as Rocephin) or intravenous placebo (inactive substance).
After the first visit to Columbia Presbyterian Medical Center, the
remaining treatments will be done in the patient's home. Patients will
be screened over the phone and in person to confirm study eligibility.

 Eligibility Ages Eligible for Study:  18 Years   -   65 Years, 
Genders Eligible for Study:  Both Accepts Healthy Volunteers

Criteria

Eligible participants must be 18-65 years old and have persistent
problems with memory, verbal fluency, or attention after having
contracted Lyme disease. Participants must be able to travel to New
York for 4-5 evaluations over the course of one year. Travel costs for
participants in need may be partially or fully reimbursable.
Participants must have had a history of well-documented Lyme disease
using the CDC's clinical criteria and a current positive IgG Western
blot or PCR. Participants must also have received, at some point in
the past at least 3 weeks of IV antibiotic therapy for Lyme disease.
Ineligible from participation are people with other major medical or
neurologic problems, people who smoke more than 10 cigarettes a day,
people with uncontrolled high blood pressure, people with allergy to
ceftriaxone (Rocephin), and people who have a history of marked
cocaine abuse. Twenty healthy subjects are also being sought for the
study.

Expected Total Enrollment:  65 Location and Contact Information Kathy
Corbera, M.D.      (212) 543-6508    culyme@aol.com
Megan Romano      (212) 543-6510    culyme@aol.com

New York
      Columbia Presbyterian Medical Center, New York,  New York, 
10032,  United States; Recruiting Megan Romano  212-543-6510   
culyme@aol.com 
Brian Fallon, M.D.,  Principal Investigator

Study chairs or principal investigators

Brian Fallon, M.D.,  Principal Investigator,  Columbia University,
College of Physicians and Surgeons, Lyme Disease Research Program   

More Information Columbia's Lyme disease research studies website
http://www.columbia-lyme.org/

Study ID Numbers  R01NS38636
Study Start Date December 1999
Record last reviewed  February 2004
NLM Identifier  NCT00037479
ClinicalTrials.gov processed this record on 2004-07-08

-----------------------------------------------------------------------

Chronic Lyme Research Study
http://www.lyme.org/fallon_spect_scan.html

CHRONIC LYME DISEASE RESEARCH STUDY
COLUMBIA UNIVERSITY
COLLEGE OF PHYSICIANS AND SURGEONS

The National Institute of Health recently awarded $4.7 Million to Dr.
Brian Fallon at Columbia University to study Chronic Lyme Disease.
This grant from the National Institute of Neurological Disorders and
Stroke funds 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. 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?   Update on the Columbia-NIH Grant   Due to the fact that
enrollment into the Columbia Brain Imaging and Treatment Study of
Chronic Lyme Disease has been slower than expected, the National
Institute of Health's Review Committee has recommended that we modify
the entry criteria slightly -- so that entry is made easier while at
the same time keeping the very strict standards for documenting the
diagnosis of Lyme Disease.
Changes we are considering include decreasing the amount of prior IV
treatment needed to be considered for the study from 8 weeks to 4
weeks.....and possibly increasing the geographic range of our study to
a few more states in the northeast.

If you or someone you know meets the following criteria, please have
that person send us an email at CULyme@aol.com or call us at
212-543-6510. Please also direct them to our web site at
www.columbia-lyme.org for more information about the study. While we
await NIH approval of these changes, we would very much like to
recruit patients who might meet criteria for the new study.

THE KEY CRITERIA ARE:

a) persistent memory or attention problems despite past treatment with
at least 4 weeks of IV antibiotics

b) current IgG positivity or current PCR positivity

c) past seropositive results: either a) IgG or IgM; or b) ELISA or
IFA.

d) good documentation in a doctor's chart of the classic clinical
symptoms of Lyme disease (e.g., erythema migrans rash, swollen joints,
Bell's palsy, meningitis, radicular pains, cardiac conduction
abnormalities, or other typical features)

e) age 18-60

Currently we are looking for patients from CT, NY, NJ, and eastern PA.
We will however explore the possibility of expanding our area of
recruitment
to other nearby states as well.
Thank you,
Brian Fallon, MD
        
----------------------------------------------------------------------------
 Welcome to Lyme Disease Research Studies
http://www.columbia-lyme.org/flatp/resstud.html

Recent, Current, and
Upcoming Research Studies If after reading about the research study,
you wish further information about the study, please send an email to
the following address: CULyme@aol.com

A National Institute of Health-funded Study of Chronic Lyme Disease
Participants: People with chronic Lyme Disease and memory or thinking
problems age 18-60

Goals: To understand more about the neurobiology and treatment of
patients with persistent cognitive problems who have already received
considerable treatment

Status of study: actively seeking patients

SPECT Imaging of Chronic Lyme Disease vs Other Disorders
Participants: People with chronic Lyme Disease age 18-55

Goals: To examine differences between SPECT images of Lyme disease vs
other disorders

Status of study: upcoming, not yet recruiting

Developmental Delay and Lyme Disease in Children
Participants: Children with Lyme Disease & Autistic Spectrum disorders
age 2-17

Goals: To explore possible associations between Lyme Disease and
autism

Status of study: In progress.

        
 Information Regarding the Columbia Persistent Lyme Encephalopathy
Study
http://www2.lymenet.org/domino/law.nsf/0/ddb8e8d4132120ed8525688b007abfd6?OpenDocument

Title: Information Regarding the Columbia Persistent Lyme
Encephalopathy Study
        Date 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

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