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

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.

Conditions

• Dementia

Interventions

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.

Sponsors & Collaborators

• Rottapharm Spain

  lead INDUSTRY

Principal Investigators

• Pau Sánchez, MD · Hospital Socio Sanitario del Hospitalet (Barcelona)

• Salvador Altimir, MD · Hospital Universitari Germans Trias i Pujol (Badalona)

• Ramón Cristófol, MD · Antic Hospital Sant Jaume i Santa Magdalena (Mataró)

• Olga Sabartés, MD · Hospital del Mar

• Enrique Arriola, MD · Fundación Matia (San Sebastián)

• José Luis González, MD · Hospital Nuestra Señora de la Montaña (Cáceres)

• Esher Martínez, MD · Hospital de la Santa Creu (Tortosa)

• Roberto Petidier, MD · Hospital Universitario de Getafe (Madrid)

• Esperanza Martin, MD · Hospital Virgen del Valle (Toledo)

• Almudena Garnica, MD · Hospital Universitari San Joan de Reus (Tarragona)

• Regina Feijoo, MD · Hosp. Sta. Caterina Gerona

• Anna Tantiña, MD · CAP Centelles (Barcelona)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2009-12-31

Completion

2010-02-28

Countries

• Spain