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

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.

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503516

Enrollment

Registered

2007-07-18

Start date

2007-06-30

Completion date

2010-02-28

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

weight loss, appetite, dementia, megestrol acetate

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.

Interventions

DRUGMegestrol acetate

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame
To evaluate the change in the body weight	24 weeks

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026