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:
Rottapharm Spain
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00503516
First received: July 17, 2007
Last updated: June 7, 2011
Last verified: June 2011
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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
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 May 23, 2013