ABSTRACT
Tacrine or Cognex is the first drug approved for the treatment of Alzheimer’s disease. It was first synthesized in the early 1940s and was discovered by the Australian physician, Dr. Adrian Albert, while trying to advance a new intravenous antiseptic for use by injured battlefield troops in World War II. With the successful production of penicillin by the British, Dr. Albert’s efforts ended and little was heard of the drug for the next several decades. Tacrine once again attracted interest when a physician, Dr. William K.
Summers, published an article in The New England Journal of Medicine [1] reporting that his studies showed the compound produced marked improvement in cognition and dexterity among Alzheimer’s patients. The FDA questioned Dr. Summers’ research methods and his conclusions [2]. However, the findings were sufficient to warrant further clinical investigation by Parke-Davis=Warner-Lambert (later acquired by Pfizer) who in-licensed the patent for tacrine from Dr. Summers. Finding a treatment that improves the quality of life for sufferers of a
disease that is marked by progressive mental deterioration is a challenge without equal in pharmaceutical research and development. The disease robs its many elderly victims of their final years. While the disease runs its course-from the early signs of memory loss to the patient’s eventual death-family members endure the crippling psychological, emotional, and financial stress of providing long-term care. The first author was a consultant to Parke-Davis=Warner-Lambert
(PD=WL) through his company, Biopharmaceutical Research Consultants, Inc. (BRCI), during the clinical development of tacrine. We provided independent linear model-based analyses [3,4] and nonlinear, mixed-effects models analyses of the primary efficacy endpoints [5-7] from the tacrine clinical trials conducted by PD=WL.
