Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia
Conditions
Brief summary
The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with BPSD.
Interventions
DRUGDAOIB
Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks
DRUGPlacebo
Intervention drug: placebo by mouth. Duration: 6 weeks
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of probable Alzheimer's disease or probable vascular dementia * For patients with vascular dementia, the post-stroke period must be more than 3 months * Mini-Mental State scores between 5-26 * Clinical Dementia Rating score equal to or greater than 1 * Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2
Exclusion criteria
* Current substance abuse or history of substance dependence in the past 6 months * Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc. * Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Pathology in Alzheimer's Disease Rating Scale | weeks 0, 2, 4, 6 | Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6 |
| Alzheimer's Disease Assessment Scale - cognitive subscale | weeks 0 and 6 | Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Caregiver Burden Interview | weeks 0 and 6 | Changes from baseline in Zarit Caregiver Burden Interview at week 6 |
| Neuropsychiatirc Inventory | weeks 0 and 6 | Change from baseline in Neuropsychiatirc Inventory at week 6 |
| Mini-Mental Status Examination | weeks 0 and 6 | Changes from baseline in Mini-Mental Status Examination at week 6 |
| Geriatric Geriatric Depression Scale | weeks 0, 2, 4, 6 | Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6 |
| Instrumental Activities of Daily Living | weeks 0 and 6 | Changes from baseline in Instrumental Activities of Daily Living at week 6 |
Countries
Taiwan
Outcome results
None listed