UnknownPhase 4

Study of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia, and Mixed Vascular and Alzheimer's Dementia

Exploratory Study to Assess the Efficacy of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia and Mixed Vascular and Alzheimer's Dementia

Lead sponsor

Sheba Medical Center

Asset

Escitalopram

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE 10-26

Primary endpoint

•Cornell Scale for Depression in Dementia (CSDD) total score

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

NCT IDNCT00229333

Org study IDSHEBA-03-3124-AS-CTIL

Timeline

Milestones

Study start2004-12 (month precision)

Study first posted2005-09-29estimated

Last update posted2006-08-29estimated

Assets

Drug assets

Escitalopram

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject meets criteria for the diagnosis of Alzheimer's dementia, or vascular dementia, or mixed alzheimer's and vascular dementia, according to Diagnostic and Statistical for Mental Disorders, Fourth Edition (DSM-IV) criteria.

•Subject meets the following criteria for depressive syndrome: DSM-IV criteria for major depressive episode; and Cornell Scale of Depression in Dementia is 18 or more.

•The depressive syndrome has been present for at least two weeks preceding study entry (Visit 1).

•The depressive syndrome must be at least moderate in severity at Visit 1 and Visit 2 (cause the subject impairment in functional capacity) and in the opinion of the investigator require pharmacological intervention.

•Score on the Mini Mental State Examination (MMSE) of 10-26 at Visit 1 and at Visit 2.

•Other possible reasons for the subject's depressive symptoms, for example, medications or other medical conditions (such as pain, infection, cancer of the pancreas, etc.), have been excluded as an etiology

Exclusion criteria

General Exclusion Criteria:

•Subjects who need placebo run-in period, and/or their caregivers are unable to comply with Study Period I medication to the extent that drug compliance in the remainder of the study would be compromised as determined by the investigator.

•Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

Diagnostic Exclusion Criteria:

•Schizophrenia

•Subjects who are judged clinically to be at serious suicidal risk at Visit 1.

•Subjects who have clinically significant psychotic symptoms at Visit 1.

•Subject has a serious neurological condition other than AD, VD or MD including, but not limited to: traumatic (head-brain) dementia, space-occupying lesion, relevant structural abnormalities on brain imaging, etc.

•Subject who underwent CVA for 3 months.

•Subject is doing well on a current antidepressant drug regimen.

Exclusionary Concurrent or Historical Illness:

•Subjects with severe hepatic or renal insufficiency.

•Hypo/hyperthyroidism

•B-12 deficiency

Exclusionary Concomitant or Historical Medications:

•Participation in a clinical trial of another investigational drug within 30 days prior to study entry (Visit 1) and/or any concurrent investigational study.

•Subjects with a history of severe adverse reaction to citalopram or escitalopram.

•Concomitant medication as specified.

•Previous treatment with escitalopram unless, in the opinion of the investigator, the patient's previous treatment was inadequate in dose and/or duration to provide an accurate assessment of the therapy.

Endpoints (2)

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.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Cornell Scale for Depression in Dementia (CSDD) total score

descriptive

Secondary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)

descriptive

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.