TerminatedPhase 3Results posted

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

An Open-label Extension Study Examining the Safety and Tolerability of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type Having Completed Study 10158

Lead sponsor

H. Lundbeck A/S

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

297

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Adverse Events (AEs)•Percentage of Patients Who Withdrew Due to Intolerance to Treatment

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 ID10252

NCT IDNCT00857233

Timeline

Milestones

Study start2004-06 (month precision)

Study first posted2009-03-06estimated

Primary completion2010-07actual (month precision)

Study completion2010-10actual (month precision)

Last update posted2012-08-29estimated

Results first posted2012-08-29estimated

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

•Ambulatory outpatients with moderate to severe dementia of the Alzheimer's type who have completed the 24-week Study 10158 and who have a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study

Exclusion criteria

•Diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.

Endpoints (12)

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

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Safety / tolerability / PK

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/registry result

Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Memantinen=244 Participants	-5.60	9.81

Function / daily living

2 endpoints

Secondary/protocol endpoint

Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score

Time frame:Baseline and Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score

Time frame:Baseline and Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Memantinen=247 Participants	-4.16	6.45

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Memantinen=247 Participants	2.11	16.12

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).

Time frame:Week 24

descriptive

Secondary/registry result

Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).

Time frame:Week 24

descriptive

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Memantinen=243 Participants	4.75	1.14

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Patients With Adverse Events (AEs)

Time frame:Baseline to Week 24

event count, event

Primary/registry result

Number of Patients With Adverse Events (AEs)

Time frame:Baseline to Week 24

event count, event

Posted result

Group	Value (number), participants	Reported bounds
MemantinePatients with AEsn=297 Participants	191	-
Patients with serious AEs (SAEs)n=297 Participants	27	-
Patients with AEs Leading to Withdrawaln=297 Participants	24	-
Patients with Baseline Eventsn=297 Participants	1	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Percentage of Patients Who Withdrew Due to Intolerance to Treatment

Time frame:Baseline to Week 24

threshold achievement, improvement

Primary/registry result/low confidence

Percentage of Patients Who Withdrew Due to Intolerance to Treatment

Time frame:Baseline to Week 24

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
Memantinen=297 Participants	8.1	-

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.