Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00767650

Purpose

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.

Condition
Aplastic Anemia

MedlinePlus related topics: Anemia

Drug Information available for: Cyclosporin Cyclosporine Alemtuzumab Campath

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	40
Study Start Date:	September 2008

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCULSION CRITERIA:
Diagnosed with aplastic anemia.
Co-enrolled on a Clinical Center CsA treatment protocol that prescribes CsA (included but not limited to 06-H-0034 (initial treatment cohort in both rabbit and horse ATG arm), 03-H-0249, 05-H-0242 and standard treatment protocol 94-H-0010).
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767650

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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.

Gijtenbeek JM, van den Bent MJ, Vecht CJ. Cyclosporine neurotoxicity: a review. J Neurol. 1999 May;246(5):339-46. Review.

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.

Study ID Numbers:	080222, 08-H-0222
Study First Received:	October 6, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00767650
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Aplastic Anemia
Cyclosporine
Campath

Neurophyschological Side Effect
Aplastic Anemia
Neurophyschological Side Effect

Study placed in the following topic categories:

Cyclosporine
Hematologic Diseases
Alemtuzumab
Anemia, Aplastic

Anemia
Aplastic anemia
Bone Marrow Diseases
Cyclosporins

ClinicalTrials.gov processed this record on January 16, 2009