Agitation Aggression in Dementia
Conditions
Brief summary
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
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.
Interventions
DRUGOxcarbazepine
Sponsors
Sykehuset Innlandet HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version) | — |
Secondary
| Measure | 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. | — |
Countries
Norway
Outcome results
None listed