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Leuprolide acetate, when used in conjunction acetylcholinesterase inhibitors, appears to stabilize the cognitive and functional decline of women with mild-to-moderate Alzheimer's disease, according to results of a Phase II study conducted by Voyager Pharmaceutical Corporation.
Leuprolide acetate, a luteinizing hormone-releasing hormone (LHRH) agonist, has been used for some time in men to suppress tumor growth in patients with hormone-responsive prostate cancer.
Acetylcholinesterase inhibitors (AChEIs) are widely used with limited success in the treatment of Alzheimer's disease
"The cognitive and functional stabilization we observed in study participants treated with the higher of the two tested doses of leuprolide acetate plus AChEIs was encouraging in the first of our two Phase II studies," said Dr. Brian Reynolds, Director of Medical and Scientific Information at Voyager.
Participants in the 48-week double blind, placebo-controlled study were 109 women ages 65 and older with mild-to-moderate Alzheimer's disease.
Voyager is currently enrolling subjects for two Phase III Alzheimer trials investigating the safety and efficacy of VP4896, a small, biodegradable implant comprised of
leuprolide acetate and a polymer.
VP4896 decreases the amount of luteinizing hormone (LH) released by the pituitary gland which, Voyager believes, may decrease or slow the progression of Alzheimer's.
Voyager said enrollment for the first trial is ahead of schedule, and it expects to complete enrollment of all 555 subjects before December 31, 2006.
Voyager's phase III trial program for VP4896 is one of only three Phase III studies investigating the effects of new therapies on the rate of cognitive decline in patients with mild to moderate Alzheimer's disease.
Source:
Medical Week staff, week of May 15, 2006
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