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

Phase 2

Terminated

• Conditions: Dementia
• Interventions: Drug: Placebo; Drug: Megestrol acetate

• Registration Number: NCT00503516
• Lead Sponsor: Rottapharm Spain

Brief 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	1 sachet of powder of placebo b.i.d. during 24 weeks
1	Megestrol acetate	Megestrol acetate 160 mg b.i.d. during 24 weeks

Primary Outcome Measures

Name	Time	Method
To evaluate the change in the body weight	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Socio Sanitario del Hospitalet; 🇪🇸 El Hospitalet, Barcelona, Spain