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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number:2006-005759-13 |
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Difficulties to recruit the patients following the inclusion criteria
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Megestrol acetate 160 mg b.i.d. during 24 weeks |
|
| 2 | Placebo Comparator | 1 sachet of powder of placebo b.i.d. during 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol acetate | Drug | 1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the change in the body weight | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pau Sánchez, MD | Hospital Socio Sanitario del Hospitalet (Barcelona) | Study Chair |
| 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 | 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) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Socio Sanitario del Hospitalet | El Hospitalet | Barcelona | 08906 | Spain |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | 1 sachet of 160 mg of placebo b.i.d. |
|
| 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 |
| Almudena Garnica, MD | Hospital Universitari San Joan de Reus (Tarragona) | Principal Investigator |
| Regina Feijoo, MD | Hosp. Sta. Caterina Gerona | Principal Investigator |
| Anna Tantiña, MD | CAP Centelles (Barcelona) | Principal Investigator |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |