Multicenter, Double Blind, Randomized, Clinical Trial, Controlled With Placebo, to Evaluate the Effect of the Treatment With 320 mg/Day of Megestrol Acetate During 24 Weeks in the Weight Loss in Mixed Dementia Patients.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- To evaluate the change in the body weight
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of body weight in patients with primary or mixed Dementia with a weight loss.
详细描述
In all geriatric patients with dementia it was prove a weight loss independently if they are institutionalized or not.There are some previous studies that indicates the effect of the megestrol acetate in the weight gain of patients with cachexia-anorexia related with neoplasia. It seems that the mechanism of development could be the same between these patients and patients with dementia. It was described an important role of a group of cytokines ( Il-6, leptin, neuropeptide Y, TNFalfa) in the development of this nutritional alteration.
Some previous pilots studies indicates that megestrol acetate has and effect in geriatric and dementia patients with a weight loss of at least 5% in the last 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of primary or mixed dementia (CIE 10criteria)
- •Weihgt loss >5% of habitual weight in the last 6 months and proteic-caloric malnutrition (MNA <17)
- •Outpatients
- •Patients that accept the participation in the study
排除标准
- •Vascular pure Dementia and secondary dementias( vascular dementia, Parkinson disease,etc)
- •Dementia in a terminal phase: category of FAST 7c in the Reisber scale
- •Concomitant treatment with steroids, androgens or other drugs with progestagens
- •Weight loss secondary to neoplasia
研究组 & 干预措施
1
Megestrol acetate 160 mg b.i.d. during 24 weeks
干预措施: Megestrol acetate (Drug)
2
1 sachet of powder of placebo b.i.d. during 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the change in the body weight
时间窗: 24 weeks
次要结局
- To evaluate the change in the appetite(24 weeks)
- To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin(24 weeks)
- Evaluate the change in the nutritional status (Mini-Nutritional Assessment)(24 weeks)
- To evaluate the change in cognitive state ( Mini-Mental State Examination)(24 weeks)
- To evaluate the safety of the treatment(24 weeks)