Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (ALADDIN) VP 104 Study

Exclusion Criteria

• •Screening laboratory test values do not indicate significant medical conditions that would interfere with their participation in and completion of the study.
• •Female;
• •Younger than 65 years of age;
• •Significant neurological disease affecting the brain or psychiatric disease other than AD, such as major depression, schizophrenia, epilepsy, Parkinson's disease, or stroke;
• •Current significant systemic illness or symptoms of organ failure;
• •Screening ECG shows evidence of a serious and/or unstable condition or a recent (within 6 months) myocardial infarction as determined by the Investigator;
• •PSA test result exceeds 4.0 ng/mL;
• •Receiving testosterone;
• •Taking a drug for the treatment of AD for less than 90 days prior to baseline; or, in the opinion of the Investigator, they are likely to either require a change in dose or discontinuation of the drug;
• •Never received cholinesterase inhibitor treatment, and the likelihood of their starting such treatment during the study is other than low, or they have taken and discontinued cholinesterase inhibitor treatment in the past and the likelihood of their resuming cholinesterase inhibitor treatment during the study is other than low;
• •Started or changed within 60 days prior to the screening visit the dosage of any drug (including OTC) that affects cognitive function, such as neuroleptics, antidepressants, anxiolytics, sedatives, hypnotics, anti-convulsants, centrally acting antihypertensive agents such as clonidine and Aldomet; or other medications that have been shown to have possible effects on cognition such as Vitamin E, nonsteroidal anti-inflammatory drugs, and statins, or if, in the Investigator's opinion, the dosage of such medication is likely to be changed during the course of this trial. Any changes in the dosage of any of these drugs during the course of the trial and the reason for the change must be fully recorded in the concomitant medication page of the patient's case report form (CRF). If a drug that affects cognition (e.g., a hypnotic or anxiolytic drug) is given on a PRN basis, such treatment should be interrupted for 12 hours before a visit, if possible;
• •Taking coumadin or anti-Parkinsonian medications;
• •Have taken other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer;
• •Taking other medications known to affect serum gonadotropin (Gn) concentrations, such as goserelin or danazol;
• •A screening HamD score of 15 or higher;
• •Abuse or dependence on alcohol or other substances satisfies criteria for DSM-IV categories 303.9 or 305;
• •Donated blood within 30 days of baseline or are likely to do so during the course of the trial;
• •History of cancer, particularly breast cancer or known or suspected prostate cancer, within the last 5 years, except for basal cell or squamous cell cancer of the skin;
• •Clinically significant bladder outlet obstruction, in the judgment of the Investigator or designated examining physician;
• •Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia, or are unable to stand or sit upright for at least 30 minutes;
• •Sleep apnea.