DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia

Study Overview
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Brief Summary
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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.

Conditions
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Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia

Intervention / Treatment
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* Drug: DAOIB
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAOIB<br>Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks | Drug: DAOIB<br>* Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo by mouth per day for 6 weeks | Drug: Placebo<br>* Intervention drug: placebo by mouth. Duration: 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Pathology in Alzheimer's Disease Rating Scale | Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6 | weeks 0, 2, 4, 6 | 
| Alzheimer's Disease Assessment Scale - cognitive subscale | Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6 | weeks 0 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatirc Inventory | Change from baseline in Neuropsychiatirc Inventory at week 6 | weeks 0 and 6 | 
| Instrumental Activities of Daily Living | Changes from baseline in Instrumental Activities of Daily Living at week 6 | weeks 0 and 6 | 
| Zarit Caregiver Burden Interview | Changes from baseline in Zarit Caregiver Burden Interview at week 6 | weeks 0 and 6 | 
| Geriatric Geriatric Depression Scale | Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6 | weeks 0, 2, 4, 6 | 
| Mini-Mental Status Examination | Changes from baseline in Mini-Mental Status Examination at week 6 | weeks 0 and 6 |