Milacemide: Safety assessment in senile dementia of the Alzheimer type

M. W. Dysken, T. D. Fakouhi, S. S. Skare, J. Mendels, P. LeWitt, Hugh Hendrie, T. C. Venable, G. L. Hantsbarger, R. L. Herting

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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 mg/day. 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 Only 8 of 209 patients completed 1 year of treatment and the remaining patients were withdrawn due to adverse effects (73), protocol violations (89), treatment failure (34), and failure to follow-up (5).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 enhancement or reduction in disease progression. It does not appear that milacemide is a viable treatment for SDAT patients.

Original languageEnglish (US)
Pages (from-to)67-72
Number of pages6
JournalDrug Development Research
Volume27
Issue number1
StatePublished - 1992

Fingerprint

Alzheimer Disease
Safety
Monoamine Oxidase
Prodrugs
Liver
Glycine
Labels
Screening
Animals
Therapeutics
Monoamine Oxidase Inhibitors
Liver Function Tests
milacemide
Treatment Failure
Disease Progression
Outpatients
Animal Models

Keywords

  • Cognition
  • Liver
  • Toxicity

ASJC Scopus subject areas

  • Organic Chemistry
  • Drug Discovery
  • Pharmacology

Cite this

Dysken, M. W., Fakouhi, T. D., Skare, S. S., Mendels, J., LeWitt, P., Hendrie, H., ... Herting, R. L. (1992). Milacemide: Safety assessment in senile dementia of the Alzheimer type. Drug Development Research, 27(1), 67-72.

Milacemide : Safety assessment in senile dementia of the Alzheimer type. / Dysken, M. W.; Fakouhi, T. D.; Skare, S. S.; Mendels, J.; LeWitt, P.; Hendrie, Hugh; Venable, T. C.; Hantsbarger, G. L.; Herting, R. L.

In: Drug Development Research, Vol. 27, No. 1, 1992, p. 67-72.

Research output: Contribution to journalArticle

Dysken, MW, Fakouhi, TD, Skare, SS, Mendels, J, LeWitt, P, Hendrie, H, Venable, TC, Hantsbarger, GL & Herting, RL 1992, 'Milacemide: Safety assessment in senile dementia of the Alzheimer type', Drug Development Research, vol. 27, no. 1, pp. 67-72.
Dysken MW, Fakouhi TD, Skare SS, Mendels J, LeWitt P, Hendrie H et al. Milacemide: Safety assessment in senile dementia of the Alzheimer type. Drug Development Research. 1992;27(1):67-72.
Dysken, M. W. ; Fakouhi, T. D. ; Skare, S. S. ; Mendels, J. ; LeWitt, P. ; Hendrie, Hugh ; Venable, T. C. ; Hantsbarger, G. L. ; Herting, R. L. / Milacemide : Safety assessment in senile dementia of the Alzheimer type. In: Drug Development Research. 1992 ; Vol. 27, No. 1. pp. 67-72.
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