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

Rottapharm

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Dementia

Treatments

Drug: Placebo

Drug: Megestrol acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00503516

EudraCT number:2006-005759-13

BO-EC-DEM-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

65 to 95 years old

Volunteers

No Healthy Volunteers

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