TerminatedPhase 3Results posted

Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease

A Randomised, Double-Blind, Parallel-Group Study Examining the Efficacy and Safety of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type

Lead sponsor

H. Lundbeck A/S

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

369

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-15

Primary endpoints

•Neuropsychiatric Inventory (NPI)•Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe

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 ID10158

NCT IDNCT00857649

Timeline

Milestones

Study start2003-12 (month precision)

Study first posted2009-03-06estimated

Primary completion2010-04actual (month precision)

Study completion2010-09actual (month precision)

Results first posted2012-01-09estimated

Last update posted2013-12-05estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Outpatients who:

•had a primary diagnosis of probable Alzheimer's Disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria, and with Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM IV TR) criteria for dementia of the Alzheimer's type

•had moderate to severe dementia, defined as a Mini Mental State Examination (MMSE) total score >=5 and <=15 at screening. Before substantial protocol amendment SA04 (dated 7 October 2004) was implemented, the MMSE total score range at screening was >=8 and <=18. Substantial protocol amendment SA07 (dated 4 September 2009) allowed patients who had previously had an MMSE score of 16 or 17 to be re-screened >6 months after their initial screening and, if there was documented evidence of cognitive decline, to be enrolled in the study

•had a Neuropsychiatric Inventory (NPI) total score >=13 and an NPI agitation/aggression subitem score >=1 at screening and baseline

•did not have vascular dementia or a modified Hachinski Ischaemia Scale score >4 at screening

Exclusion criteria

•Evidence of clinically significant active disease, evidence of other neurological disorders, and previous treatment with memantine

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

Behavior / neuropsychiatric

Global cognition

Function / daily living

Caregiver / quality of life

Global cognition

2 endpoints

Primary/protocol endpoint

Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.

Time frame:Baseline to Week 24

change from baseline, improvement

Primary/registry result

Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard error
Memantinen=159 Participants	-2.34	0.76
Placebon=165 Participants	-1.86	0.75

Mean Difference (Final Values)-0.4895% CI-2.30 - 1.34p0.603ANCOVA

Function / daily living

2 endpoints

Secondary/protocol endpoint

Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.

Time frame:Baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.

Time frame:Baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard error
Memantinen=136 Participants	-4.36	0.67
Placebon=140 Participants	-2.56	0.65

Mean Difference (Final Values)-1.8095% CI-3.29 - -0.32p0.017ANCOVA

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard error
Memantinen=159 Participants	-3.90	1.24
Placebon=165 Participants	-5.13	1.23

Mean Difference (Final Values)1.2395% CI-1.75 - 4.21p0.418ANCOVA

Secondary/protocol endpoint

Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard error
Memantinen=134 Participants	-0.26	0.79
Placebon=139 Participants	-1.16	0.79

Mean Difference (Final Values)0.9095% CI-1.03 - 2.83p0.360ANCOVA

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Efficacy of Memantine on Global Condition Using CIBIC-plus.

Time frame:Baseline to Week 24

descriptive

Secondary/registry result

Efficacy of Memantine on Global Condition Using CIBIC-plus.

Time frame:Baseline to Week 24

descriptive

Posted result

Group	Value (mean), Scores on a scale	Standard error
Memantinen=135 Participants	4.68	0.11
Placebon=140 Participants	4.63	0.11

Mean Difference (Final Values)0.0595% CI-0.22 - 0.31p0.734ANCOVA

Publications (1)

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

Herrmann N, Gauthier S, Boneva N, Lemming OM; 10158 Investigators. A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease. Int Psychogeriatr. 2013 Jun;25(6):919-27. doi: 10.1017/S1041610213000239. Epub 2013 Mar 8.
PMID23472619via RESULT

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.