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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00767650 |
This study will use neuropsychological tests to look at nervous system side effects of Cyclosporine (CsA) in patients with aplastic anemia. CsA is used as part of an immunosuppressive regimen in treating severe aplastic anemia. The drug can produce nervous system side effects, such as tremor and, less commonly, insomnia, anxiety, headache, confusion or seizures. This study will look at effects of CsA on intellectual ability, depression, anxiety, attention, concentration, memory, perception, coordination, and thought processing in patients
Patients 15 years of age or older who have severe aplastic anemia may be eligible for this study if they:
Participants undergo neuropsychological testing. In addition, they provide blood samples and their clinical data are reviewed for things that may influence the interpretation of findings from the testing, such as results of blood tests, types of medications taken, number of transfusions required, etc. The procedures are as follows:
Before first dose of cyclosporine:
Patients provide a half teaspoon of blood for this study at the same time blood is collected for their primary treatment protocol.
6 months and 12 months after starting cyclosporine
Condition |
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Aplastic Anemia |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia |
Estimated Enrollment: | 40 |
Study Start Date: | September 2008 |
Cyclosporine (CsA) is widely used in the treatment of aplastic anemia as well as to provide immunosuppression after transplantation. CsA has a spectrum of neurologic and more subtle, poorly investigated neuropsychological functional effects. In the NHLBI, a unique opportunity exists to evaluate changes in neuropsychological function following CsA in a large cohort of aplastic anemia patients accrued to NHLBI treatment protocols.
With increased success in treating blood diseases with immunosuppressive therapy or stem cell transplantation that utilize CsA in the treatment regimen, patients are enjoying prolonged survival during which quality of life becomes an increasingly relevant concern. We therefore propose this natural history protocol designed to evaluate neuropsychological functioning before, during, and after CsA administration in severe aplastic anemia patients.
The primary objective is to evaluate changes in attention, language, memory, spatial/motor and executive function domains following CsA therapy using well established neuropsychological tests including the Neuropsychological Assessment Battery (NAB) Screening Module, Revised Hopkins Verbal Learning Test, Revised Brief Visual-spatial Memory Test, Judgment of Line Orientation test, Grooved Pegboard, Trail Making Test and the two performance subsets in Wechsler Adult Intelligence Scale-III. IQ test by Wechsler Abbreviated Scale of Intelligence and depression/anxiety level will be screened once prior to formal testing. Measures will also be correlated with clinical status, standard CsA side effects, CsA drug levels and relevant biochemical lab values at each time point to control the testing accuracy and explore potential correlation.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080222, 08-H-0222 |
Study First Received: | October 6, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00767650 History of Changes |
Health Authority: | United States: Federal Government |
Aplastic Anemia Cyclosporine Campath |
Neurophyschological Side Effect Aplastic Anemia Neurophyschological Side Effect |
Cyclosporine Immunologic Factors Aplastic Anemia Hematologic Diseases Alemtuzumab |
Anemia, Aplastic Anemia Bone Marrow Diseases Immunosuppressive Agents Cyclosporins |
Immunologic Factors Hematologic Diseases Physiological Effects of Drugs Anemia, Aplastic |
Anemia Bone Marrow Diseases Immunosuppressive Agents Pharmacologic Actions |