Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease
The purpose of this study is to evaluate the safety and tolerability of an extended release formulation of the drug galantamine using a rapid dose escalation regimen.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Galantamine ER Open Label Rapid Dose Escalation Trial in Alzheimer's Disease|
- The primary end point occurs at Week 8. The primary outcome measures will be tolerability and safety through rates of adverse events.
- The secondary end point occurs at Week 12. The secondary outcome measure will be the Mini Mental State Examination score.
|Study Start Date:||May 2004|
|Study Completion Date:||April 2005|
To improve dosing convenience of the current formulation of galantamine, a new once daily dosing Extended Release (ER) formulation was developed. In a different large study, in which approximately 900 patients with Alzheimer's disease participated, efficacy of the Extended Release formulation was confirmed. During the first 8 weeks of treatment, nausea and vomiting occurred less frequently with the Extended Release than Intermittent Release formulation. This suggests that patients might better tolerate a rapid dose escalation to the initial maintenance dose of 16mg daily, thereby improving the risk/benefit ratio during the first 4 weeks of therapy, i.e. receiving more drug sooner. The trial objectives are: 1) to demonstrate the safety and tolerability of galantamine Extended Release 16 mg daily when titrated from 8 mg daily after one week; 2) to evaluate the effect of galantamine Extended Release on cognition as measured by the Mini Mental State Examination. Results from prior trials show that galantamine Intermittent Release (twice a day dosing) has a high rate of adverse events when dose escalations occur at one-week intervals. Therefore, current galantamine labelling recommends that the drug dose be escalated once every 4 weeks. The study hypotheis is that the rapid dose escalation of the Extended Release formulation in subjects with Alzheimer's disease is safe and well tolerated. Comparison of adverse event rates will be made to the first 8 weeks Reminyl Extended Release group of another trial in which the Extended Release formulation was titrated from 8 mg daily to 16 mg daily at 4 weeks. Subjects will receive galantamine Extended Release capsules by mouth starting at 8 mg daily and after one week will be titrated up to 16 mg daily. This dose will be maintained for 11 additional weeks.
8 mg of Galantamine Extended Release Capsules once daily for one week. After one week will be titrated up to 16 mg daily for 11 weeks.
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|