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

Primary Purpose

Dementia

Status

Terminated

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Megestrol acetate

Placebo

About this trial

This is an interventional treatment trial for Dementia focused on measuring weight loss, appetite, dementia, megestrol acetate

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Socio Sanitario del Hospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Megestrol acetate 160 mg b.i.d. during 24 weeks

1 sachet of powder of placebo b.i.d. during 24 weeks

Outcomes

Primary Outcome Measures

To evaluate the change in the body weight

Secondary Outcome Measures

To evaluate the change in the appetite

To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin

Evaluate the change in the nutritional status (Mini-Nutritional Assessment)

To evaluate the change in cognitive state ( Mini-Mental State Examination)

To evaluate the safety of the treatment

Full Information

NCT ID

NCT00503516

First Posted

July 17, 2007

Last Updated

June 7, 2011

Sponsor

Rottapharm Spain

1. Study Identification

Unique Protocol Identification Number

NCT00503516

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Terminated

Why Stopped

Difficulties to recruit the patients following the inclusion criteria

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rottapharm Spain

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

Keywords

weight loss, appetite, dementia, megestrol acetate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Megestrol acetate 160 mg b.i.d. during 24 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

1 sachet of powder of placebo b.i.d. during 24 weeks

Intervention Type

Drug

Intervention Name(s)

Megestrol acetate

Intervention Description

1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 sachet of 160 mg of placebo b.i.d.

Primary Outcome Measure Information:

Title

To evaluate the change in the body weight

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

To evaluate the change in the appetite

Time Frame

24 weeks

Title

To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin

Time Frame

24 weeks

Title

Evaluate the change in the nutritional status (Mini-Nutritional Assessment)

Time Frame

24 weeks

Title

To evaluate the change in cognitive state ( Mini-Mental State Examination)

Time Frame

24 weeks

Title

To evaluate the safety of the treatment

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: