Trial | NCT00503516  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    megestrol ...

  • Study Participants

    39
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.
Study Started
Jun 30
2007
Primary Completion
Dec 31
2009
Study Completion
Feb 28
2010
Last Update
Jun 08
2011
Estimate

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.

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

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
No Results Posted