SAVANNAH, GA. — An extended-release formulation of memantine 28 mg applied once daily was safe and well-tolerated in patients with moderate to severe Alzheimer's disease who participated in a 52-week, open-label, fixed-dose study.
Dr. Barnett Meyers of Weill Medical College at Cornell University, White Plains, N.Y., and his colleagues presented the study, which was funded by Forest Laboratories, at the annual meeting of the American Association for Geriatric Psychiatry.
Memantine (Namenda) has been approved for the treatment of moderate to severe Alzheimer's disease (AD). It's currently administered in twice-daily, immediate-release doses of 10 mg each.
A previous 24-week trial indicated that a once-daily 28-mg formulation of memantine (memantine ER) was safe and effective for patients with moderate to severe AD who were taking cholinesterase inhibitors (Alzheimers Dement. 2008;4[Suppl. 1]:T793).
Of 253 outpatients who were screened, 164 were either titrated to the target dose of memantine ER 28 mg daily over 4 weeks (75 of the 128 patients in this group completed the trial) or were switched from twice daily, immediate-release memantine 10 mg (23 of 36 patients completed the trial). All patients were 50 years or older, with similar baseline characteristics and a diagnosis of probable AD.
Of 150 patients who reported treatment-emergent adverse events, 8 (5%) experienced events that were determined to be related to the study medication.
Overall, 44 patients (27%) experienced a serious adverse event, and none of the 12 deaths that occurred during the trial was determined to be related to treatment.
During treatment, 18% of patients gained weight, 13% lost weight, and 10% had high blood urea nitrogen, Dr. Meyers and his colleagues reported in their poster.
The researchers concluded that patients taking the 10-mg twice-daily dose can safely switch to memantine ER without a titration period.