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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503516
Recruitment Status : Terminated (Difficulties to recruit the patients following the inclusion criteria)
First Posted : July 18, 2007
Last Update Posted : June 8, 2011
Information provided by:
Rottapharm Spain

July 17, 2007
July 18, 2007
June 8, 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 ]
Same as current
Complete list of historical versions of study NCT00503516 on Archive Site
  • 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 ]
Same as current
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.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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 Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
65 Years to 95 Years   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT number:2006-005759-13
Not Provided
Not Provided
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
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