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

NCT ID: NCT00503516

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-02-28

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Megestrol acetate 160 mg b.i.d. during 24 weeks

Group Type: EXPERIMENTAL

Megestrol acetate

Intervention Type: DRUG

1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks

2

1 sachet of powder of placebo b.i.d. during 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 sachet of 160 mg of placebo b.i.d.

Interventions

Megestrol acetate

1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks

Intervention Type: DRUG

Placebo

1 sachet of 160 mg of placebo b.i.d.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rottapharm Spain

INDUSTRY

Sponsor Role: lead

Responsible Party

Madaus, S.A.

Principal Investigators

Pau Sánchez, MD

Role: STUDY_CHAIR

Hospital Socio Sanitario del Hospitalet (Barcelona)

Salvador Altimir, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Germans Trias i Pujol (Badalona)

Ramón Cristófol, MD

Role: PRINCIPAL_INVESTIGATOR

Antic Hospital Sant Jaume i Santa Magdalena (Mataró)

Olga Sabartés, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Enrique Arriola, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Matia (San Sebastián)

José Luis González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nuestra Señora de la Montaña (Cáceres)

Esher Martínez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de la Santa Creu (Tortosa)

Roberto Petidier, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Getafe (Madrid)

Esperanza Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Valle (Toledo)

Almudena Garnica, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari San Joan de Reus (Tarragona)

Regina Feijoo, MD

Role: PRINCIPAL_INVESTIGATOR

Hosp. Sta. Caterina Gerona

Anna Tantiña, MD

Role: PRINCIPAL_INVESTIGATOR

CAP Centelles (Barcelona)

Locations

Hospital Socio Sanitario del Hospitalet

El Hospitalet, Barcelona, Spain

Countries

Spain

Other Identifiers

EudraCT number:2006-005759-13

Identifier Type: -

Identifier Source: secondary_id

BO-EC-DEM-02

Identifier Type: -

Identifier Source: org_study_id