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

Condition(s) targeted: Agitation Aggression in Dementia

Intervention: Oxcarbazepine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sykehuset Innlandet HF

Official(s) and/or principal investigator(s):
Oskar H Sommer, MD, Principal Investigator, Affiliation: Sykehuset Innlandet HF

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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.

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.

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Sykehuset Innlandet HF, Reinsvoll, Oppland 2840, Norway

Starting date: September 2005
Ending date: October 2006
Last updated: March 20, 2007