Brain Imaging and Retreatment Study of Persistent Lyme Disease
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|ClinicalTrials.gov Identifier: NCT00037479|
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : December 7, 2005
|Condition or disease||Intervention/treatment||Phase|
|Lyme Disease Lyme Neuroborreliosis||Drug: ceftriaxone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Official Title:||PET and MRI Imaging of Persistent Lyme Encephalopathy|
|Study Start Date :||December 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037479
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Brian Fallon, M.D.||Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program|