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

Dementia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00503516
• Other study ID #: BO-EC-DEM-02
• Secondary ID: EudraCT number:2
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 17, 2007
• Last updated: June 7, 2011
• Start date: June 2007
• Est. completion date: February 2010

Study information

• Verified date: June 2011
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Weight Loss

Intervention

Drug:
• Megestrol acetate
1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
• Placebo
1 sachet of 160 mg of placebo b.i.d.

Locations

Country	Name	City	State
Spain	Hospital Socio Sanitario del Hospitalet	El Hospitalet	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the change in the body weight		24 weeks	No
Secondary	To evaluate the change in the appetite		24 weeks	No
Secondary	To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin		24 weeks	No
Secondary	Evaluate the change in the nutritional status (Mini-Nutritional Assessment)		24 weeks	No
Secondary	To evaluate the change in cognitive state ( Mini-Mental State Examination)		24 weeks	No
Secondary	To evaluate the safety of the treatment		24 weeks	Yes