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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
1 sachet of 160 mg of placebo b.i.d.
Hospital Socio Sanitario del Hospitalet
El Hospitalet, Barcelona, Spain
To evaluate the change in the body weight
Time frame: 24 weeks
To evaluate the change in the appetite
Time frame: 24 weeks
To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin
Time frame: 24 weeks
Evaluate the change in the nutritional status (Mini-Nutritional Assessment)
Time frame: 24 weeks
To evaluate the change in cognitive state ( Mini-Mental State Examination)
Time frame: 24 weeks
To evaluate the safety of the treatment
Time frame: 24 weeks
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