TerminatedPhase 2 / PHASE3

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.

Lead sponsor

Rottapharm Spain

Asset

Megestrol acetate

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Primary or mixed dementia

Primary endpoint

•The body weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBO-EC-DEM-02

SecondaryEudraCT number:2006-005759-13

NCT IDNCT00503516

Timeline

Milestones

Study start2007-06 (month precision)

Study first posted2007-07-18estimated

Primary completion2009-12actual (month precision)

Study completion2010-02actual (month precision)

Last update posted2011-06-08estimated

Assets

Drug assets

Megestrol acetate

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Safety / tolerability / PK

Global cognition

1 endpoint

Secondary/protocol endpoint

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

Time frame:24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

To evaluate the safety of the treatment

Time frame:24 weeks

descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

To evaluate the change in the body weight

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

To evaluate the change in the appetite

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:24 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.