Milacemide: Safety assessment in senile dementia of the Alzheimer type

✍ Scribed by Maurice W. Dysken; T. Daniel Fakouhi; Stacy S. Skare; Joseph Mendels; Peter LeWitt; Hugh C. Hendrie; Thomas C. Venable; Gary L. Hantsbarger; Robert L. Herting

• Publisher: John Wiley and Sons
• Year: 1992
• Tongue: English
• Weight: 381 KB
• Volume: 27
• Category: Article
• ISSN: 0272-4391
• DOI: 10.1002/ddr.430270108

✦ Synopsis

Milacemide, both an MAO-B inhibitor and a prodrug for glycine, has demonstrated cognitive enhancing effects in animal models, in cognitively intact young and elderly, and has been suggested as a potential treatment for senile dementia of the Alzheimer type (SDAT). This multicenter open-label trial evaluated the safety and potential efficacy of long-term milacemide treatment in 209 SDAT outpatients (50-87 years of age). Milacemide treatment was initiated at 400 mg/day and was titrated up to a maximum dose of 1,600 mglday. Laboratory screening tests, adverse effects reports, the Clinical Global Impression Scale, and the Patient Global Improvement Rating Scale were collected to assess patients' physical and cognitive functioning. Only 8 of 209 patients completed 1 year of treatment and the remaining patients were withdrawn due to adverse effects (73), protocol violations (89), treatment failure (34), and failure to follow-up (5). Liver function tests became elevated in 145 patients and required study withdrawal for 67 of these patients. There was no evidence of cognitive