NCT00503516

Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia Patients

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.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Rottapharm Spain · Industry
• Sex: All
• Age: 65 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dementia

Interventions

Type	Name	Description
DRUG	Megestrol acetate	1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
DRUG	Placebo	1 sachet of 160 mg of placebo b.i.d.

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2007-07-18
• Last updated: 2011-06-08

Locations

1 site across 1 country: Spain