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CompletedPhase 4

Memantine for Agitation and Aggression in Severe Alzheimer's Disease

Phase IV-An Open-Label Prospective Study of Memantine in Institutionalized Patients With Severe Alzheimer's Disease and Significant Behavioural and Psychological Symptoms of Dementia

Asset

Memantine

Listed sites

2

Recruiting sites

-

Enrollment

31

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤15•AD symptomatic therapy: stable ≥3 months

Primary endpoints

•Neuropsychiatric Inventory (NPI)•Clinical Global Impression of Change

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 IDLundbeck-11267
NCT IDNCT00401167

Timeline

Milestones

Study start2006-11 (month precision)
Study first posted2006-11-17estimated
Primary completion2010-01actual (month precision)
Study completion2010-01actual (month precision)
Last update posted2024-01-31actual

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Signed informed consent obtained from a legally acceptable representative
•Male or female > 65 years of age, residing in long-term care
•Diagnosis and Statistical Manual of Mental Disorders (DSM-IV-TR) diagnosis of Dementia of the Alzheimer's type (code 290.1)
•Mini Mental State Examination total score ≤ 15
•Neuropsychiatric Inventory-Nursing Home Version total score > 10, and a score > 1 on the agitation/aggression subscale
•A current order for any prescription medication for behavioral and psychological symptoms of dementia (e.g. benzodiazepine, antipsychotic, trazodone), with at least 1 dose used in the prior 3 months
•Patients with a current order for any regularly administered psychotropic (example, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, trazodone, atypical antipsychotics, typical antipsychotics or cholinesterase inhibitors) must have been on a stable dose for 3 months prior to entry

Exclusion criteria

•Current evidence of any uncontrolled medical illness that would interfere with the subject's participation in the study
•Dementia due to any etiology other than Alzheimer's Disease
•Subjects experiencing significant difficulties ingesting oral medications

Endpoints (8)

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
4
Function / daily living
1
Caregiver / quality of life
1
Other clinical outcomes
1
Other (unclassified)
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Activities of Daily Living

Time frame:Baseline, 3 months

descriptive

Behavior / neuropsychiatric

4 endpoints
Primary/protocol endpoint

Neuropsychiatric Inventory Nursing Home Version

Time frame:Screening, Baseline, 1 month, 2 months, 3 months

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory Nursing Home Version

Time frame:Screening, baseline, 1 month, 2 months, 3 months

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory Burden Subscale

Time frame:Screening, baseline, 1 month, 2 months, 3 months

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Cohen Mansfield Agitation Inventory

Time frame:Baseline, 1 month, 2 months, 3 months

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Quality of Life in Late Stage Dementia

Time frame:Baseline, 3 months

categorical status, descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Clinical Global Impression of Change

Time frame:Baseline, 1 month, 2 months, 3 months

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Modified Nursing Care Assessment Scale

Time frame:Baseline, 3 months

descriptive

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

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.