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

Study Overview
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Brief Summary
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We intend to conduct a phase III b trial to verify Oxcarbazepine's effect in agitation and aggression in patients with dementia. We designed the study as a randomized, double-blind, placebo-controlled multi center trial. Hundred patients will be included. The treatment period will be eight weeks, with a further follow up of four weeks. The primary outcome measure will be the reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version). Secondary outcomes are reduction in aggression as measured by BARS (Behavior Agitation Rating Scale)and reduction in the burden to health-care personnel as measured by NPI-NH.

Detailed Description
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Inclusion criteria: Patients of either gender, 55 years of age or older, living in a nursing home diagnosed with or a strong suspicion of dementia of Alzheimer's type or vascular origin, and BPSD in form of agitation / aggression as measured by subscale of NPI-NH and BARS. Exclusion criteria: Patients that have any other kind of dementia as FTD, PD or LBD; patients with hepatic or renal failure, or diseases that make it impossible to follow the study schedule; patients on antiepileptics or antipsychotics.

Official Title
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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

Conditions
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Agitation Aggression in Dementia

Intervention / Treatment
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* Drug: Oxcarbazepine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxcarbazepine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in aggression as measured by BARS (Behavior Agitation Rating Scale), |  |  | 
| Reduction in the burden to health-care personnel as measured by NPI-NH. |  |  | 
| Evaluate the concomitant use of acute medication (haloperidol), and compare the frequency and dosage used in the two groups. |  |  |