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CompletedPhase 3

The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)

The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD) - An Eight Week Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi Center Trial. A Phase III Study

Asset

Oxcarbazepine

Listed sites

1

Recruiting sites

-

Enrollment

100

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 IDEudraCT number: 2004-005266-20
NCT IDNCT00145691
SecondarySponsor's Protocol Code: 1500

Timeline

Milestones

Study start2005-09 (month precision)
Study first posted2005-09-05estimated
Study completion2006-10actual (month precision)
Last update posted2007-03-21estimated

Assets

Drug assets

Oxcarbazepine

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Alzheimer's dementia, vascular dementia or mixed forms of both according to ICD10 (F00, F01) criteria.
•The patient is 55 years of age or older.
•Residents at a nursing home and who have been there for at least 4 weeks prior to inclusion.
•Signed informed consent by the patient or the relatives signed agreement that they have no reservations against patient's participation in the study.
•At least one week history of agitation or aggression, score 6 or more in NPI-NH-subscale agitation/aggression

Exclusion criteria

•Previous intolerability or known hypersensitivity to Oxcarbazepine or its equivalents
•Low sodium serum levels <135 mmol/L
•Severe impaired renal function (creatinine clearance <30 ml/min, calculated with Cockroft + Gault's formula)
•Hepatic failure (transaminases (g-GT and ALAT > 3 times upper normal limit).
•Patients with AV-block II and III and all kinds of arrhythmia necessitating a treatment.
•Severe somatic diseases that afford a change of medication and will compromise the attendance to the study.
•Patients on cyclosporine.
•Patients in need of strong analgesics like opioids as codeines
•Patients taking carisoprodol
•Alcohol or drug abuse during the last 12 months (used a higher dosage than prescribed)
•The patient has been on ChEIs or memantine for less than 3 months or any change in the dosage during the last 2 weeks.
•The patient is taking antiepileptics or antipsychotics (may be included two weeks after the use of antipsychotics has been ended).
•The patient is taking MAOI or lithium
•The patient with a dementia of type PDD, FTD or DLB
•The patients with a severe or acute neurological disease (e.g. epilepsy, acute CVE, severe Parkinson's disease, acute confusion) or a severe psychiatric disorder like bipolar disorder, schizophrenia...
•The patients who have participated in another clinical trial during the last 3 months.
•The patients who have been randomized to the same study before.

Endpoints (4)

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
3
Other (unclassified)
1

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Reduction in aggression as measured by BARS (Behavior Agitation Rating Scale),

change from baseline, improvement

Secondary/protocol endpoint

Reduction in the burden to health-care personnel as measured by NPI-NH.

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Evaluate the concomitant use of acute medication (haloperidol), and compare the frequency and dosage used in the two groups.

event count, event

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.