Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia

NCT00767650 | Completed

• 2 other identifiers: 08022208-H-0222
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aplastic Anemia

Keywords

Aplastic Anemia; Cyclosporine; Campath; Neurophyschological Side Effect

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Young NS, Calado RT, Scheinberg P. Current concepts in the pathophysiology and treatment of aplastic anemia. Blood. 2006 Oct 15;108(8):2509-19. doi: 10.1182/blood-2006-03-010777. Epub 2006 Jun 15.

  PMID: 16778145 BACKGROUND

• Gijtenbeek JM, van den Bent MJ, Vecht CJ. Cyclosporine neurotoxicity: a review. J Neurol. 1999 May;246(5):339-46. doi: 10.1007/s004150050360.

  PMID: 10399863 BACKGROUND

• 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. doi: 10.1182/blood-2004-03-1155. Epub 2004 Jul 13.

  PMID: 15251983 BACKGROUND

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: September 23, 2008
• Study Completion: June 28, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-06-28

Locations

US (1)