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Journal of Geriatric Psychiatry and Neurology
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Evaluation of Multiple Doses of Milacemide in the Treatment of Senile Dementia of the Alzheimer's Type

Neal R. Cutler, MD

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

T. Daniel Fakouhi, PhD, MBA

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

Ward T. Smith, MD

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

Hugh C. Hendrie, MD

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

Fumisuke Matsuo, MD

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

John J. Sramek, PharmD

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

Robert L. Herting, MD, PhD

California Clinical Trials (Drs Cutler and Sramek), Beverly Hills, CA, Searle Research and Development (Drs Fakouhi and Herting), Skokie, IL, the Pacific Northwest Clinical Research Center (Dr Smith), Portland, OR, the Indiana University Medical Center (Dr Hendrie), Indianapolis, IN, and the University of Utah School of Medicine (Dr Matsuo), Salt Lake City, UT.

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.

Journal of Geriatric Psychiatry and Neurology, Vol. 6, No. 2, 115-119 (1993)
DOI: 10.1177/089198879300600210


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J Geriatr Psychiatry NeurolHome page
T. D. Fakouhi, S. S. Jhee, J. J. Sramek, C. Benes, P. Schwartz, G. Hantsburger, R. Herting, E. A. Swabb, and N. R. Cutler
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J Geriatr Psychiatry Neurol, October 1, 1995; 8(4): 226 - 230.
[Abstract] [PDF]



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