Evaluation of Multiple Doses of Milacemide in the Treatment of Senile Dementia of the Alzheimer's Type

Neal R. Cutler, T. Daniel Fakouhi, Ward T. Smith, Hugh C. Hendrie, Fumisuke Matsuo, John J. Sramek, Robert L. Herting

Research output: Contribution to journalArticle

13 Scopus citations

Abstract

A multicenter, double-blind, placebo-controlled, parallel group study was conducted to assess the safety and efficacy of three doses of milacemide in the treatment of patients with senile dementia of the Alzheimer type of mild to moderate severity. Patients were randomly assigned to receive one of three dosages of milacemide (400, 800, or 1200 mg/day) or placebo for 4 weeks followed by a single-blind 4-week placebo period. One hundred forty-eight men and women older than 50 years of age were enrolled, and 129 patients completed the study. The differences among treatment groups were not statistically different with respect to total scores on the Alzheimer's Disease Assessment Scale or any items and subscales that were examined, nor were significant differences on the Clinical Global Impression Scale found. Clinically significant increases in liver function tests, specifically aspartate aminotransferase and alanine aminotransferase (AST and ALT), were reported for five of the patients receiving milacemide, requiring their withdrawal from the study.

Original languageEnglish (US)
Pages (from-to)115-119
Number of pages5
JournalJournal of Geriatric Psychiatry and Neurology
Volume6
Issue number2
DOIs
StatePublished - Apr 1993

ASJC Scopus subject areas

  • Clinical Neurology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health

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