DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
Overview
- Phase
- Phase 2
- Intervention
- DAOIB
- Conditions
- Behavioral and Psychological Symptoms in Alzheimer's Disease
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Behavioral Pathology in Alzheimer's Disease Rating Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Chieh-Hsin Lin
Dr
Chang Gung Memorial Hospital
Eligibility Criteria
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
Arms & Interventions
DAOIB
Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks
Intervention: DAOIB
Placebo
Placebo by mouth per day for 6 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Behavioral Pathology in Alzheimer's Disease Rating Scale
Time Frame: 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
Time Frame: weeks 0 and 6
Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
Secondary Outcomes
- Neuropsychiatirc Inventory(weeks 0 and 6)
- Instrumental Activities of Daily Living(weeks 0 and 6)
- Zarit Caregiver Burden Interview(weeks 0 and 6)
- Geriatric Geriatric Depression Scale(weeks 0, 2, 4, 6)
- Mini-Mental Status Examination(weeks 0 and 6)