STUDY OF LEUPROLIDE ACETATE DEPOT IN THE TREATMENT OF AD IN MEN

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本试验旨在研究激素类药物亮丙瑞林改善记忆、延缓阿尔茨海默病（AD）进展的安全性和有效性。FDA尚未批准亮丙瑞林用于治疗阿尔茨海默病患者，因此亮丙瑞林被认为是本研究中的实验性药物。 这项研究将招募65岁以上被诊断患有阿尔茨海默病的男性。那些通过筛选和资格要求的人将被随机分为三组。第一组将接受22.5 mg/12周剂量的亮丙瑞林，第二组将接受33.25 mg/12周剂量的亮丙瑞林，第三组将接受称为安慰剂的非活性物质。受试者将接受两次注射，在研究期间每12周（3个月）一次在每个髋关节注射亮丙瑞林或安慰剂。 由于已知亮丙瑞林会降低血液中天然睾酮的水平，因此接受亮丙瑞林的患者还将接受睾酮替代品，其形式为凝胶，每天应用于皮肤。接受亮丙瑞林安慰剂的患者将接受含有安慰剂且不含睾酮的试管。在研究开始和研究结束时进行的记忆测试结果的变化将用于显示亮丙瑞林治疗阿尔茨海默病的有效性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This trial is to investigate the safety and effectiveness of leuprolide, a hormone drug, to improve memory and slow the progress of Alzheimer's disease (AD). The FDA has not approved leuprolide to treat patients with Alzheimer's disease, and so leuprolide is considered an experimental drug in this study. This study will be enrolling men over 65 years of age who have been diagnosed with Alzheimer's disease. Those who pass the screening and eligibility requirements will be randomized into one of three groups. The first group will receive leuprolide at a dosage of 22.5 mg per 12 weeks, the second group will receive leuprolide at a dosage of 33.25 mg per 12 weeks and the third group will receive an inactive substance called a placebo. Participants will receive two injections, one in each hip of either leuprolide or placebo once every 12 weeks (3 months) during the study. Since leuprolide is known to reduce levels of natural testosterone in the blood, those receiving leuprolide will also receive testosterone replacement in the form of a gel to be applied daily to the skin. Those receiving a placebo for leuprolide will receive tubes containing a placebo and no testosterone. Changes in the results of memory testing done at the beginning of the study and at the end of the study will be used to show the effectiveness of leuprolide in the treatment of Alzheimer's disease.