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

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rottapharm Spain
• Treatments: Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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