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MAGD
CompletedPhase 4Memantine for Agitation in Dementia
Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Asset
Memantine
Listed sites
2
Recruiting sites
-
Enrollment
153
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 19
Primary endpoint
•Cohen-Mansfield
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.
3. Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).
4. Clinically significant agitation that requires treatment.
5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.
6. Age >/= 55
Exclusion criteria
1. Memantine usage in the 4 weeks prior to the start of the study.
2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
3. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
4. Antiparkinsonian medication.
5. Hypersensitivity to memantine or any of the excipients in the formulation.
6. Severe renal impairment.
7. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
10. Severe, unstable or poorly controlled medical illness.
11. Any disability that may interfere with the patient completing the study procedure.
12. Active malignancy.
13. Delirium, pain or any medical illness as a clear cause of agitation.
14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.
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
Global cognition
1 endpointSevere Impairment Battery 6+12 weeks
Time frame:2 weeks
descriptive
Behavior / neuropsychiatric
2 endpointsNeuropsychiatric Inventory 6+12 weeks
Time frame:2 weeks
Neuropsychiatric Inventory (NPI)
descriptive
Incidents of agitation
Time frame:2 weeks
descriptive
Caregiver / quality of life
1 endpointQuality of Life 6+12 weeks
Time frame:2 weeks
descriptive
Other clinical outcomes
1 endpointClinical Global Impression 6+ 12 weeks
Time frame:2 weeks
descriptive
Other (unclassified)
3 endpointsCohen-Mansfield
Time frame:2 weeks
descriptive
Co-meds
Time frame:2 weeks
descriptive
Use of rescue protocol
Time frame:2 weeks
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
- PMID22567095via DERIVED
Provenance
Sources
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.