Clinical trial NCT00503516: Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia Patients
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Dementia
Keywords: weight loss, appetite, dementia, megestrol acetate
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate the change in the body weight
timeFrame: 24 weeks
Secondary outcomes:
measure: To evaluate the change in the appetite
timeFrame: 24 weeks
measure: To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin
timeFrame: 24 weeks
measure: Evaluate the change in the nutritional status (Mini-Nutritional Assessment)
timeFrame: 24 weeks
measure: To evaluate the change in cognitive state ( Mini-Mental State Examination)
timeFrame: 24 weeks
measure: To evaluate the safety of the treatment
timeFrame: 24 weeks
Other outcomes:
Locations:
city: El Hospitalet
country: Spain
facility: Hospital Socio Sanitario del Hospitalet
state: Barcelona
Study officials:
affiliation: Hospital Socio Sanitario del Hospitalet (Barcelona)
name: Pau Sánchez, MD
role: STUDY_CHAIR
affiliation: Hospital Universitari Germans Trias i Pujol (Badalona)
name: Salvador Altimir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antic Hospital Sant Jaume i Santa Magdalena (Mataró)
name: Ramón Cristófol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Olga Sabartés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Matia (San Sebastián)
name: Enrique Arriola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Nuestra Señora de la Montaña (Cáceres)
name: José Luis González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de la Santa Creu (Tortosa)
name: Esher Martínez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Getafe (Madrid)
name: Roberto Petidier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Valle (Toledo)
name: Esperanza Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari San Joan de Reus (Tarragona)
name: Almudena Garnica, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Sta. Caterina Gerona
name: Regina Feijoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CAP Centelles (Barcelona)
name: Anna Tantiña, MD
role: PRINCIPAL_INVESTIGATOR
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