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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia Drug: Megestrol acetate Drug: Placebo Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Megestrol acetate 160 mg b.i.d. during 24 weeks
Drug: Megestrol acetate
1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks

Placebo Comparator: 2
1 sachet of powder of placebo b.i.d. during 24 weeks
Drug: Placebo
1 sachet of 160 mg of placebo b.i.d.

Primary Outcome Measures :
  1. To evaluate the change in the body weight [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To evaluate the change in the appetite [ Time Frame: 24 weeks ]
  2. To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin [ Time Frame: 24 weeks ]
  3. Evaluate the change in the nutritional status (Mini-Nutritional Assessment) [ Time Frame: 24 weeks ]
  4. To evaluate the change in cognitive state ( Mini-Mental State Examination) [ Time Frame: 24 weeks ]
  5. To evaluate the safety of the treatment [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503516

Hospital Socio Sanitario del Hospitalet
El Hospitalet, Barcelona, Spain, 08906
Sponsors and Collaborators
Rottapharm Spain
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)

Responsible Party: Anna Anguera, Research Manager, Madaus, S.A. Identifier: NCT00503516     History of Changes
Other Study ID Numbers: BO-EC-DEM-02
EudraCT number:2006-005759-13
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Rottapharm Spain:
weight loss, appetite, dementia, megestrol acetate

Additional relevant MeSH terms:
Weight Loss
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants