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

点击翻译按钮获取中文摘要

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.