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NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAOIB | Experimental | oral, for 24 weeks |
|
| Placebo | Placebo Comparator | oral, for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOIB | Drug | oral, for 24 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 | Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst). | week 0, 8, 16, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 | Clinician's Interview-Based Impression of Change plus Caregiver Input score is a global assessment of change based on a comprehensive, semi-structured interview which includes caregiver-supplied information. It is a 7-point rating scale ranging from 1-7, where 1 represents markedly improved; 4, no change; and 7, markedly worse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | 886 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40405827 | Derived | Lin CH, Wang SH, Lane HY. Sodium benzoate, a D-amino acid oxidase inhibitor, improved short-term memory in patients with mild cognitive impairment in a randomized, double-blind, placebo-controlled clinical trial. Psychiatry Clin Neurosci. 2025 Aug;79(8):466-472. doi: 10.1111/pcn.13841. Epub 2025 May 23. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Drug |
oral, for 24 weeks |
|
| week 8, 16, 24 |
| Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24 | ADCS-MCI-ADL appears to be a suitable instrument for evaluating activities of daily living in mild cognitive impairment. Its scores range from 0 (worst) to 78 (best). | week 0, 8, 16, 24 |
| Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24 | The SF-36 consists of eight sections which assess the quality of life. | week 0, 8, 16, 24 |
| Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24 | The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (verbal and nonverbal, Wechsler Memory Scale), learning and memory tests (verbal and visual, Wechsler Memory Scale) | week 0, 24 |