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

This study has been terminated.
(Difficulties to recruit the patients following the inclusion criteria)
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00503516
First received: July 17, 2007
Last updated: June 7, 2011
Last verified: June 2011

July 17, 2007
June 7, 2011
June 2007
December 2009   (final data collection date for primary outcome measure)
To evaluate the change in the body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the change in the body weight [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00503516 on ClinicalTrials.gov Archive Site
  • To evaluate the change in the appetite [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Evaluate the change in the nutritional status (Mini-Nutritional Assessment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the change in cognitive state ( Mini-Mental State Examination) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the safety of the treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the change in the appetite [ Time Frame: 24 weeks ]
  • To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin [ Time Frame: 24 weeks ]
  • Evaluate the change in the nutritional status (Mini-Nutritional Assessment) [ Time Frame: 24 weeks ]
  • To evaluate the change in cognitive state ( Mini-Mental State Examination) [ Time Frame: 24 weeks ]
  • To evaluate the safety of the treatment [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dementia
  • 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.
  • Experimental: 1
    Megestrol acetate 160 mg b.i.d. during 24 weeks
    Intervention: Drug: Megestrol acetate
  • Placebo Comparator: 2
    1 sachet of powder of placebo b.i.d. during 24 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
65 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00503516
BO-EC-DEM-02, EudraCT number:2006-005759-13
No
Anna Anguera, Research Manager, Madaus, S.A.
Rottapharm Spain
Not Provided
Study Chair: Pau Sánchez, MD Hospital Socio Sanitario del Hospitalet (Barcelona)
Principal Investigator: 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, Barcelona
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)
Principal Investigator: 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)
Rottapharm Spain
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP