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MAGD

CompletedPhase 4

Memantine 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 diseaseMMSE 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

Org study ID2005-005087-93
SecondaryISRCTN 24953404
NCT IDNCT00371059

Timeline

Milestones

Study first posted2006-09-01estimated
Study start2007-09actual (month precision)
Primary completion2009-06actual (month precision)
Study completion2009-09actual (month precision)
Last update posted2022-04-06actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
3
Behavior / neuropsychiatric
2
Global cognition
1
Caregiver / quality of life
1
Other clinical outcomes
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Severe Impairment Battery 6+12 weeks

Time frame:2 weeks

descriptive

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Neuropsychiatric Inventory 6+12 weeks

Time frame:2 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Incidents of agitation

Time frame:2 weeks

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Quality of Life 6+12 weeks

Time frame:2 weeks

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Clinical Global Impression 6+ 12 weeks

Time frame:2 weeks

descriptive

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Cohen-Mansfield

Time frame:2 weeks

descriptive

Secondary/protocol endpoint/low confidence

Co-meds

Time frame:2 weeks

descriptive

Secondary/protocol endpoint/low confidence

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.

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.