Aplastic Anemia Clinical Trial
Official title:
Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia
Verified date | June 28, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
- are co-enrolled in a Clinical Center protocol in which they will receive CsA
- have not taken CsA for 6 months before enrolling in this study
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 are asked about prior problems with their nervous system, prior treatment for
their aplastic anemia (including transfusions), prior infections, and current
medications. They then complete the following sets of tests:
- Battery 1: A set of three tests that measure intellectual ability, level of depression
(if any) and level of anxiety (if any).
- Battery 2: A set of seven tests that measure changes in the central nervous system and
how these changes affect attention, concentration, memory, perception, coordination, and
thought processing.
- 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
- Patients are asked about treatment for their aplastic anemia (including transfusions),
infections, and changes in medications that have occurred since they started taking
cyclosporine. They then repeat the set of tests in Battery 2.
- Patients provide a half teaspoon of blood for this study at the same time blood is
collected for their primary treatment protocol.
Status | Completed |
Enrollment | 7 |
Est. completion date | June 28, 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility |
- INCULSION CRITERIA: - Diagnosed with aplastic anemia. - Co-enrolled on a Clinical Center CsA treatment protocol that prescribes CsA (included but not limited to initial treatment cohort in both rabbit and horse ATG arm for the aplastic anemia patients). - Age greater than or equal to 15 years old. EXCLUSION CRITERIA: - Prior use of cyclosporine within 6 months to next line of treatment. - History of learning disability (i.e. dyslexia). - Unable to read and speak English (the neuropsychological testing tools are validated for use in English speaking subjects only). - Life expectancy less than six months or when clinical status prevents full performance with testing. - Either adult patients or guardians for the minor patient, unable to comprehend the investigational nature of the study and provide informed consent. - Inability or unwillingness to come to Clinical Center for the 6-month and 12-month follow-up appointments. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Gijtenbeek JM, van den Bent MJ, Vecht CJ. Cyclosporine neurotoxicity: a review. J Neurol. 1999 May;246(5):339-46. Review. — View Citation
Syrjala KL, Dikmen S, Langer SL, Roth-Roemer S, Abrams JR. Neuropsychologic changes from before transplantation to 1 year in patients receiving myeloablative allogeneic hematopoietic cell transplant. Blood. 2004 Nov 15;104(10):3386-92. Epub 2004 Jul 13. — View Citation
Young NS, Calado RT, Scheinberg P. Current concepts in the pathophysiology and treatment of aplastic anemia. Blood. 2006 Oct 15;108(8):2509-19. Epub 2006 Jun 15. Review. — View Citation
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