A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Calculated difference image of pre-treatment and on-treatment PET scans.
研究概览
简要总结
Treatment with testosterone can improve performance on tests of spatial ability in men with low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean an improved ability to get around in one's environment without getting lost or injured. This could have a positive impact on both patients and those who care for them. We will investigate what areas of the brain are involved in these improvements in spatial ability. This will be done using a PET scan, which creates a 3-dimensional image of the brain that can allow us to see how the brain functions.
详细描述
Volunteers will be treated with a prescription testosterone gel applied to the shoulder or other body area each day. This treatment will continue for 6 months. Subjects will undergo a PET scan at the beginning of the study and after approximately 2 months of treatment. Subjects will undergo some cognitive testing throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's disease diagnosis, based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V)
- •Total testosterone < 300 ng/dL and/or calculated free testosterone < 50 pg/ml
- •Sufficient English to perform cognitive testing
- •Stable on concomitant medications for 1 month prior to starting study
排除标准
- •history of prostate cancer
- •history of breast cancer
- •gonadal endocrine disorders
- •current major psychiatric illness (excluding depression)
- •significant uncontrolled systemic illness
- •recent myocardial infarction (within 6 months)
- •renal or hepatic disease, sleep apnea
- •history of alcoholism or substance abuse within the past year
- •history of head injury with loss of consciousness greater than 1 hour
- •testosterone or other androgen treatment within past 3 months
- •history of taking other drugs that might interfere with the results of the study (ie, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme inducers, barbiturates)
- •symptomatic BPH: prostatic symptoms, prostatic masses or induration on rectal examination
- •prostate specific antigen (PSA) >4.0 mg/mL
- •hemoglobin > 17 mg/dL
- •generalized skin disease that could affect the absorption of testosterone gel (ie, psoriasis).
- •potentially agitated or uncooperative for procedures
结局指标
主要结局
Calculated difference image of pre-treatment and on-treatment PET scans.
次要结局
- Change in cognitive function at 8-week intervals over a 6-month period.