CompletedPhase 2 / PHASE3Results posted

Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment

Effects of Combined Memantine (Namenda) Plus Escitalopram (Lexapro) Treatment in Elderly Depressed Patients With Cognitive Impairment

Lead sponsor

New York State Psychiatric Institute

Assets

Escitalopram / Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Age 50-90

Primary endpoint

•Selective Reminding Test - Total Immediate Recall (SRT-IR)

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 ID6277R

NCT IDNCT01876823

Timeline

Milestones

Study start2006-04 (month precision)

Primary completion2010-03actual (month precision)

Study completion2010-03actual (month precision)

Study first posted2013-06-13estimated

Last update posted2014-10-24estimated

Results first posted2014-10-24estimated

Assets

Drug assets

Escitalopram Memantine

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Of either sex, age greater than 49 years old

2. Meets criteria for both "depression" and "cognitive impairment".

3. Study Criteria for "depression":

i.Patients who meet DSM-IV criteria for Major Depression, Dysthymic Disorder, or Dysthymia symptoms criteria of minimum 6 month duration (not the 2 year DSM-IV criteria).

ii.24-item HAM-D greater than 13; and

iii.Clinical Global Impression (CGI) for severity of Depression greater than 2 (absolute score at least mild to moderate depression on a 7-point scale)

4. Study Criteria for "cognitive deficit":

i. Subjective memory complaint ii.Mini Mental Status Exam (MMSE) greater than 24; and at least one of a, b, or c:

1. less than 3 on MMSE 5 min delay on recall

2. scores on 2 neuropsychological tests greater than 1 Standard Deviation (SD) below standardized norms, or

3. score on 1 neuropsychological tests greater than 2 SD below standardized norms.

Neuropsychological tests for inclusion criteria (subset of larger battery):

Selective Reminding Test with delay Wechsler Memory Scale (WMS): Visual Reproduction - with delay, % savings from immed to delay Controlled Oral Word Association Test Trails B Digit symbol subtest of Wechsler Adult Intelligence Scale (WAIS)-III Continuous Performance Test

iii.CGI for severity of Cognitive deficit greater than 2 (absolute score on a 7-point scale:1=no deficit to 7=severe deficit).

iv.Clinical Dementia Rating (CDR) = 0 or 0.5

5. Willing and capable of giving informed consent

Exclusion criteria

1. Meets Criteria for dementia (DSM-IV) or probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA criteria)

2. Meets criteria for:

1. schizophrenia

2. alcohol or substance dependence or abuse within the last 6 months.

3. Suicidal attempt in last 6 months or current suicidal intent.

4. Patients currently on an effective antidepressant medication

5. Use of cholinesterase inhibitors in the last year.

6. Neurological disease including stroke, epilepsy, or other neurodegenerative disorders.

7. An acute, severe or unstable medical condition such as metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis.

8. Patients who can not tolerate being tapered off antidepressant medication (i.e. greater than a 25% incr. in baseline HAM-D) or has a history indicating patient is unlikely to tolerate psychotropic washout.

9. Patient with a history of non-response to Citalopram or es-citalopram

Endpoints (20)

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

Memory

Executive function / language

Behavior / neuropsychiatric

Global cognition

Other clinical outcomes

Other (unclassified)

Global cognition

2 endpoints

Other/protocol endpoint

Conversion to Dementia Using Clinical Dementia Rating (CDR)

Time frame:Baseline, Week 48

time to event, event

Other_pre_specified/registry result

Conversion to Dementia Using Clinical Dementia Rating (CDR)

Time frame:Baseline, Week 48

time to event, event

Posted result

Group	Value (number), participants	Reported bounds
Es-citalopram and Memantine Treatmentn=35 Participants	1	-

Memory

6 endpoints

Primary/protocol endpoint

Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)

Time frame:baseline, 48 weeks

change from baseline, improvement

Primary/registry result

Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)

Time frame:baseline, 48 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Es-citalopram and Memantine Treatmentn=35 Participants	7.5	15

Secondary/protocol endpoint

Change in Wechsler Memory Scale-III (WMS-III)

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Selective Reminding Test - Delayed Recall (SRT-DR)

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/registry result

Change in Wechsler Memory Scale-III (WMS-III)

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Es-citalopram and Memantine Treatmentn=35 Participants	9.9	32.8

Secondary/registry result

Change in Selective Reminding Test - Delayed Recall (SRT-DR)

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Es-citalopram and Memantine Treatmentn=35 Participants	1.2	3.9

Executive function / language

4 endpoints

Secondary/protocol endpoint

Change in Trails B

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Trails A

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/registry result

Change in Trails B

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
Es-citalopram and Memantine Treatmentn=35 Participants	-36.3	74.5

Secondary/registry result

Change in Trails A

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
Es-citalopram and Memantine Treatmentn=35 Participants	1.9	41.2

Behavior / neuropsychiatric

4 endpoints

Other/protocol endpoint

Change in 24-item HAMD

Time frame:Baseline, Week 48

change from baseline, improvement

Other/protocol endpoint

Change in Clinical Global Impression - Depression Change

Time frame:Baseline, Week 48

change from baseline, improvement

Other_pre_specified/registry result

Change in 24-item HAMD

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Es-citalopram and Memantine Treatmentn=35 Participants	-15.2	4.4

Other_pre_specified/registry result

Change in Clinical Global Impression - Depression Change

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Es-citalopram and Memantine TreatmentCognitive Global Impression at Baselinen=35 Participants	4.1	0.5
Cognitive Global Impression at Final Visit (WK 48)n=35 Participants	2.1	1.2

Other clinical outcomes

2 endpoints

Other/protocol endpoint

Change in Clinical Global Impression - Cognitive Change

Time frame:Baseline, Week 48

change from baseline, improvement

Other_pre_specified/registry result

Change in Clinical Global Impression - Cognitive Change

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Es-citalopram and Memantine TreatmentCGI-Cognitive Change (Baseline)n=35 Participants	3.6	0.6
Clinical Global Impression-Cogntive Change (WK 48)n=35 Participants	2.7	0.9

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Change in Treatment Emergent Side Effects (TESS)

Time frame:Baseline, Week 48

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Treatment Emergent Side Effects (TESS)

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Es-citalopram and Memantine TreatmentTreatment Emergent Side Effects (Baseline)n=35 Participants	6.6	4.2
Treatment Emergent Side Effects (WK 48)n=35 Participants	3.2	2.9

Publications (49)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.