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Escitalopram

CompletedPhase 4

Escitalopram for the Treatment of Depression in Alzheimer's Disease

A 12-Week Randomized, Double-blind, Parallel-group, Placebo-controlled Trial With and Open-label, 12-week Extension, Multicenter to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease

Asset

Escitalopram

Listed sites

1

Recruiting sites

-

Enrollment

84

actual

Study population

Alzheimer’s disease

Key I/E criterion

Alzheimer's disease

Primary endpoint

CSDD from baseline after 12 weeks of between treatment groups

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 IDADD_E_2010
NCT IDNCT01841125

Timeline

Milestones

Study start2011-11 (month precision)
Study first posted2013-04-26estimated
Primary completion2014-07actual (month precision)
Study completion2014-07actual (month precision)
Last update posted2014-08-13estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1) over the age of 50

2) Medical diagnostic criteria must meet the standard.

1. Subject diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA Criteria.

2. Subject with three or more symptoms of the Olin depression (major depressive episode) diagnostic criteria.

3. clinical dementia rating (CDR) of 0.5 to 2

4. MMSE 10 ~ 26 (K-MMSE)

5. GDS-15 ≥ 5 points

3) When screening, Cholinesterase inhibitors taking a minimum of four weeks or more stable subject.

4) During the clinical trials, Subject does not change the capacity of Cholinesterase Inhibitors.

5) MRI or CT results within 24 months of subject with Alzheimer's disease (AD)

6) Participation in clinical trials to determine their own and written informed consent form and subject who actively perform clinical procedure including the questionnaire. But the subjects with cognitive dysfunction that cannot voluntarily make the decision, can be determined by an authorized representative to participate in.

7) Subjects must be accompanied their guardian to every visit. More than three days a week, more than 4 hours per day, spend the day with the guardian

Exclusion criteria

1. If you are taking other depression drugs within 4 weeks before the start of the clinical trials(e.g. SSRI, Stablon, TCA, wellbutrin, ixel)

2. If you have any other mental illness (bipolar disorder, schizophrenia, etc.)

3. If you have a serious medical illness (heart failure, angina pectoris, myocardial infarction, arteriosclerosis, etc.) or psychiatric illness.

4. Seizures, brain surgery, organic brain disease and history of organic affective disorder and at the brain MRI, abnormalities other than brain atrophy.

5. If you have a history of the test drug hypersensitivity

6. If you are taking memantin (dementia)

7. If you participated in another clinical trial within 3 months.

8. If pregnant or fertile women, who have not received sterilization or if you do not want to use an effective method of contraception.

9. In laboratory tests, if you have kidney failure or liver failure.

10. If you have history or habitual drinking or a history of drug abuse.

11. Uncontrolled diabetes or hypertension.

12. If determined to be inappropriate for clinical trials.

Endpoints (10)

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)
5
Behavior / neuropsychiatric
3
Global cognition
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Change from baseline in K-MMSE at week 12 and 24.

Time frame:24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in ADAS-Cog at week 12 and 24.

Time frame:24 weeks

ADAS-Cog

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.

Time frame:24weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.

Time frame:24 weeks

change from baseline, improvement

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Change from baseline in NPIQ at week 12 and 24.

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in S-IADL at week 12 and 24.

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in CDR at week 12 and 24.

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in CDR sum of box at week 12 and 24.

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.