Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

Not Recruiting

Trial ID: NCT00688376


The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.

Official Title

Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

Stanford Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health


1. The subject must have received at least one cycle of chemotherapy and/or cranial
   radiation, and must have completed this treatment at least one year before screening
   takes place for entry into this study.

   2. Subjects may be male or female; age range: 6 - 17.5 years; weight ≥ 20 kg. They must
   be physically healthy and able to move about, with or without aids, must be living in
   the community, and must have adequate motor skills as shown by tests that will be
   given at the time of screening. The subject's eyesight and hearing must be good enough
   to allow cooperation with tests and physical examinations. Additionally, they must be
   able to swallow tablets.

   3. There must be subjective complaints by subject and/or parent of difficulties in school
   or other daily activities, possibly related to impairments in attention. These
   difficulties must have emerged after treatment for cancer and must still be present 12
   months after cessation of treatment. There must also be objective evidence for this
   impairment, as shown by a test that will be given to the subject at the time of

   4. The IQ must be >70 according to tests that will be given at the time of screening.

   5. The first language in which the subject learned to read and write must be one that
   uses Roman lettering (a, b, c, etc.) and Arabic numerals (1, 2, 3, etc.).

   6. The subject must not have previously taken any drugs in the class known as
   cholinesterase inhibitors.

   7. A parent or legal guardian must be available who is willing and able to complete all
   of the outcome measures, to administer medications, and to accompany the subject to
   the required clinic visits.

   8. Subjects with diabetes or thyroid disease may still be eligible if certain medical
   requirements are satisfied.

   9. Female subjects who could become pregnant must undergo pregnancy testing and must
   agree to use contraception.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

   1. Inability to perform the required tests (for example, because of aphasia, motor
   deficits affecting the dominant hand, or mental retardation).

   2. Motor coordination not sufficient, according to tests to be conducted at the time of

   3. Recurrence of cancer. If this happens, the subject will have to withdraw from the

   4. Mental retardation/developmental disability.

   5. Certain medications, such as methylphenidate, are not allowed during the study.

   6. Major depression.

   7. Problems with the digestive tract that could affect the subject's ability to absorb
   the study drug.

   8. Hypersensitivity to a chemical class known as piperidine derivatives.

   9. Certain other medical conditions as determined by clinical staff.

10. Alcoholism, drug abuse, or organic brain disease other than that caused by the cancer
   or its treatment.

11. Pregnancy, nursing, or unwillingness to undergo pregnancy testing if requested by
   clinical staff.

12. Pregnancy, lactation or plans to become pregnant, or unwilling to take a screening
   Beta-human chorionic gonadotropin (ßhCG) test if a female >10 years of age.

13. If sexually active, unwillingness to use birth control (males and females).

14. Plans for certain types of elective surgery that would occur while the study is in

15. Plans for travel or other events that would interfere with the study schedule.

16. Active treatment with another investigational drug within 3 months of the screening


drug: Donepezil hydrochloride

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Lew

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