Milacemide: a placebo-controlled study in senile dementia of the Alzheimer type.

OBJECTIVE

Milacemide, a MAO-B inhibitor that is also a prodrug for glycine, was tested as a treatment for senile dementia of the Alzheimer type (SDAT) because of its potential for enhancing cognition in animal models of impaired learning and memory.

DESIGN

Double-blind, placebo-controlled, randomized clinical trial.

SETTING

Sixteen study sites, both university-affiliated and private.

PATIENTS

A total of 228 outpatients (116 men and 112 women) with SDAT, ranging in age from 49-93 years.

INTERVENTION

1200 mg/day milacemide treatment for 1 month (113 patients received milacemide, and 115 patients received placebo).

MAIN OUTCOME MEASURES

Alzheimer's Disease Assessment Scale and the Mini-Mental State Examination.

RESULTS

Milacemide-treated SDAT patients did not show significant improvement in any of the outcome measures used. Significant elevations in liver enzymes in four subjects were of sufficient magnitude to necessitate withdrawal from the study.

CONCLUSIONS

Milacemide does not appear to be an effective treatment in enhancing cognition in SDAT patients.