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Published on: January 26, 2015
by Medical Research:
Currently, there is no treatment for Alzheimer’s disease that halts or slows its progression. Alzheimer’s disease is a neurodegenerative disorder resulting in memory loss and impairments of behavioral, language and visuo-spatial skills. A growing body of biological, preclinical and epidemiological data suggests that the age-related changes in hormones of the hypothalamic-pituitary-gonadal (HPG) axis are a major etiological factor in Alzheimer’s diseases.
The changes in these hormones include not only the decline in the sex steroids, (i.e. 17-estradiol and testosterone), but the elevations in gonadotropin-releasing hormone and luteinizing hormone. In particular there are encouraging epidemiological studies involving the use of Lupron Depot which suppresses these hormones. In one such study which included hundreds of thousands of patients it was found that men who had prostate disease and were treated with Lupron Depot had a 34 to 55 percent decreased risk of developing Alzheimer’s disease compared with prostate-cancer patients who didn’t receive the drug.
The efficacy and safety of leuprolide acetate (Lupron Depot®) in the treatment of Alzheimer’s disease (AD) was conducted in a 48 week, double-blind, placebo-controlled, dose-ranging study in women aged 65 years or older with mild to moderate AD. Post-menopausal women were chosen for this study because they no longer produce sex steroids and the treatment would only affect GnRH and LH; whereas in men there would also be a loss of the testosterone they are still producing.
A total of 109 women with mild to moderate Alzheimer’s disease and a Mini-Mental State Exam score between 12 and 24 inclusive were randomized to low dose (LD) Lupron Depot® (11.25 mg leuprolide acetate), high dose (HD) Lupron Depot® (22.5 mg leuprolide acetate) or placebo (P) injections every 12 weeks. There were no statistically significant differences in primary efficacy parameters (ADAS-Cog and ADCS-CGIC).
However, in a subgroup analysis of patients taking an acetylcholine esterase inhibitor (AChEI) there was a statistically significant benefit in the high dose group compared to both the low dose and placebo groups as determined by the ADAS-Cog, a memory test (mean decline: HD: 0.18, LD: 4.21 and P: 3.30), ADCS-CGIC, a caregiver index of decline (% subjects experiencing decline: HD: 38, LD: 82 and P: 63), and ADCS-ADL, a measure of activities of daily living (mean decline: HD: -0.54, LD: -8.00 and P: -6.85), respectively, after one year.
These data indicate that cognitive function is preserved in women treated with high dose Lupron who were already using AChEI’s. Lupron is a drug with a good safety record that has been used for decades in this age group. Another clinical study of this combination therapy (i.e. Lupron and Aricept) is required to replicate the efficacy of this treatment for Alzheimer’s disease in women.
This promising combination therapy (AChEI and Lupron Depot) warrants testing as a treatment and for prevention of those at risk of Alzheimer’s disease. Clinical trials of this combination therapy together with add-back testosterone in men are also warranted. Unfortunately, there is no intellectual property protection for this treatment making it unlikely that a pharmaceutical company will take the lead.
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