The included patients are all elderly people with dementia of Alzheimer or vascular type. Their dementia is moderate or severe and they all have Behavioral or Psychological Symptomes (BPSD). MedDRA version: 8.1 Level: LLT Classification code 10057678 Term: Vascular dementia
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Dementia of Alzheimer or vascular type. 2. BPSD 3. Regulary intake of antipsychotics or antidepressivas daily for three months or more. 4. Living in Nursing homes for the last three months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other kind of dementia. 2. Schizofrenia, depression or another psychiatric disease. 3. Expected life-duration less than three months. 4. Terminal illness. 5. Acute infection, uncontrolled Diabetes Mellitus or another somatic disease wich may interfere with the dementia and its symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the effect of antipsychotics and antidepressivas on BPSD in patients with dementia. 2. To measure Quality of Life for patients with dementia before and after discontinuing antipsychotics and antidepressivas.;Secondary Objective: 1. To translate Severe Impairment Battery into Norwegian and to validate the scorings for Norwegian conditions and patients. ;Primary end point(s): 1. Changes in scores at the neuropsychiatric Inventory (NPI) 2. Changes in Extra Pyramidal side-effects. 3. Changes in Quality of Life registrations. 4. Changes in Cornell's depression scale. 5. Changes in body weight. | — |
Countries
Norway