Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia

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Brief Title

Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia

Official Title

Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia

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.
    

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.
    


Study Type

Observational




Condition

Aplastic Anemia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

7

Start Date

September 23, 2008

Completion Date

June 28, 2011


Eligibility Criteria

        -  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.
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00767650

Organization ID

080222

Secondary IDs

08-H-0222


Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)


Study Sponsor

, , 


Verification Date

June 28, 2011