Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Madaus, S.A. |
---|---|
Information provided by: | Madaus, S.A. |
ClinicalTrials.gov Identifier: | NCT00503516 |
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.
Condition | Intervention | Phase |
---|---|---|
Dementia |
Drug: Megestrol acetate Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 220 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Megestrol acetate 160 mg b.i.d. during 24 weeks
|
Drug: Megestrol acetate
1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
|
2: Placebo Comparator
1 sachet of powder of placebo b.i.d. during 24 weeks
|
Drug: Placebo
1 sachet of 160 mg of placebo b.i.d.
|
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.
Ages Eligible for Study: | 65 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna Anguera, MD, phD | 34-93-298-8200 | aanguera@madaus.es |
Spain, Barcelona | |
Hospital Socio Sanitario del Hospitalet | Recruiting |
El Hospitalet, Barcelona, Spain, 08906 | |
Principal Investigator: Pau Sánchez, MD |
Study Chair: | Pau Sánchez, MD | Hospital Socio Sanitario del Hospitalet (Barcelona) |
Principal Investigator: | Salvador Altimir, MD | Hospital Universitari Germans Trias i Pujol (Badalona) |
Principal Investigator: | Ramón Cristófol, MD | Antic Hospital Sant Jaume i Santa Magdalena (Mataró) |
Principal Investigator: | Olga Sabartés, MD | Hospital del Mar (Barcelona) |
Principal Investigator: | Enrique Arriola, MD | Fundación Matia (San Sebastián) |
Principal Investigator: | José Luis González, MD | Hospital Nuestra Señora de la Montaña (Cáceres) |
Principal Investigator: | Esher Martínez, MD | Hospital de la Santa Creu (Tortosa) |
Principal Investigator: | Roberto Petidier, MD | Hospital Universitario de Getafe (Madrid) |
Principal Investigator: | Esperanza Martin, MD | Hospital Virgen del Valle (Toledo) |
Principal Investigator: | Juan Carlos Duran, MD | Hospital Juan Grande (Jerez de la Frontera) |
Principal Investigator: | Almudena Garnica, MD | Hospital Universitari San Joan de Reus (Tarragona) |
Principal Investigator: | Regina Feijoo, MD | Hosp. Sta. Caterina Gerona |
Study ID Numbers: | BO-EC-DEM-02, EudraCT number:2006-005759-13 |
Study First Received: | July 17, 2007 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00503516 |
Health Authority: | Spain: Spanish Agency of Medicines |
weight loss, appetite, dementia, megestrol acetate |
Central Nervous System Diseases Brain Diseases Megestrol Cognition Disorders Body Weight Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Weight Loss Body Weight Changes Dementia Megestrol Acetate Delirium |
Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Nervous System Diseases Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female |
Central Nervous System Stimulants Reproductive Control Agents Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |