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
  Purpose

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 Intervention Phase
Dementia
Drug: Megestrol acetate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • To evaluate the change in the body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 39
Study Start Date: June 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503516

Locations
Spain
Hospital Socio Sanitario del Hospitalet
El Hospitalet, Barcelona, Spain, 08906
Sponsors and Collaborators
Rottapharm Spain
Investigators
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)
  More Information

No publications provided

Responsible Party: Anna Anguera, Research Manager, Madaus, S.A.
ClinicalTrials.gov Identifier: NCT00503516     History of Changes
Other Study ID Numbers: BO-EC-DEM-02, EudraCT number:2006-005759-13
Study First Received: July 17, 2007
Last Updated: June 7, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on July 29, 2014