Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia Patients - Full Text View

Sponsored by:	Madaus, S.A.
Information provided by:	Madaus, S.A.
ClinicalTrials.gov Identifier:	NCT00503516

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 II Phase III

MedlinePlus related topics: Dementia Weight Control

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Madaus, S.A.:

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 ]

Estimated Enrollment:	220
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator 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

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

Contacts

Contact: Anna Anguera, MD, phD

34-93-298-8200

aanguera@madaus.es

Locations

Spain, Barcelona
Hospital Socio Sanitario del Hospitalet	Recruiting
El Hospitalet, Barcelona, Spain, 08906
Principal Investigator: Pau Sánchez, MD

Sponsors and Collaborators

Madaus, S.A.

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:	Juan Carlos Duran, MD	Hospital Juan Grande (Jerez de la Frontera)
Principal Investigator:	Almudena Garnica, MD	Hospital Universitari San Joan de Reus (Tarragona)
Principal Investigator:	Regina Feijoo, MD	Hosp. Sta. Caterina Gerona

More Information

Study ID Numbers:	BO-EC-DEM-02, EudraCT number:2006-005759-13
Study First Received:	July 17, 2007
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00503516
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Madaus, S.A.:

weight loss, appetite, dementia, megestrol acetate

Study placed in the following topic categories:

Central Nervous System Diseases
Brain Diseases
Megestrol
Cognition Disorders
Body Weight
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Weight Loss
Body Weight Changes
Dementia
Megestrol Acetate
Delirium

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Nervous System Diseases
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female

Central Nervous System Stimulants
Reproductive Control Agents
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on January 16, 2009