Agitation Aggression in Dementia Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment