Conditions: Attention Impairment
Keywords: Attention cancer chemotherapy donepezil acetylcholinesterase inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
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.

Detailed description:
This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Donepezil hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.

During the Blinded Extension Phase, all subjects will receive active treatment (donepezil). intervention 2: During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.

During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).

Protocol document: