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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Dementia

Intervention / Treatment
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* Drug: Megestrol acetate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Megestrol acetate 160 mg b.i.d. during 24 weeks | Drug: Megestrol acetate<br>* 1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks<br>|
| Placebo Comparator: 2<br>1 sachet of powder of placebo b.i.d. during 24 weeks | Drug: Placebo<br>* 1 sachet of 160 mg of placebo b.i.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change in the body weight |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, appetite, dementia, megestrol acetate