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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAOIB | Experimental | Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo by mouth per day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOIB | Drug | Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsien-Yuan Lane, MD, PhD | China Medical University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | 886 | Taiwan | |||
| China Medical University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33881530 | Derived | Lin CH, Chen PK, Wang SH, Lane HY. Effect of Sodium Benzoate on Cognitive Function Among Patients With Behavioral and Psychological Symptoms of Dementia: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216156. doi: 10.1001/jamanetworkopen.2021.6156. | |
| 32110025 | Derived | Lin CH, Yang HT, Chen PK, Wang SH, Lane HY. Precision Medicine of Sodium Benzoate for the Treatment of Behavioral and Psychological Symptoms of Dementia (BPSD). Neuropsychiatr Dis Treat. 2020 Feb 20;16:509-518. doi: 10.2147/NDT.S234371. eCollection 2020. |
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| Placebo |
| Drug |
Intervention drug: placebo by mouth. Duration: 6 weeks |
|
| 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 |
| Taichung |
| 886 |
| Taiwan |
| ID | Term |
|---|---|
| D001519 | Behavior |
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