NCT00503516

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

July 17, 2007

Last Update Submit

June 7, 2011

Conditions

Dementia

Keywords

weight loss, appetite, dementia, megestrol acetate

Outcome Measures

Primary Outcomes (1)

  • To evaluate the change in the body weight

    24 weeks

Secondary Outcomes (5)

  • To evaluate the change in the appetite

    24 weeks

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

    24 weeks

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

    24 weeks

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

    24 weeks

  • To evaluate the safety of the treatment

    24 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Megestrol acetate

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Megestrol acetateDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Socio Sanitario del Hospitalet

El Hospitalet, Barcelona, 08906, Spain

Location

MeSH Terms

Conditions

DementiaWeight Loss

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pau Sánchez, MD

    Hospital Socio Sanitario del Hospitalet (Barcelona)

    STUDY CHAIR

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

ES(1)