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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAOI-A group | Experimental |
| |
| DAOI-B group | Experimental |
| |
| DAOI-C group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOI-A group | Drug | DAOI with A dose |
| |
| DAOI-B group |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 | Cognitive assessment | week 0, 8, 16, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24 | Global assessment | week 8, 16, 24 |
| Change from baseline in speed of processing (Category Fluency) at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 886 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40764372 | Derived | Lin CH, Lane HY. Sodium benzoate treatment decreased amyloid beta peptides and improved cognitive function among patients with Alzheimer's disease: secondary analysis of a randomized clinical trial. Transl Psychiatry. 2025 Aug 5;15(1):264. doi: 10.1038/s41398-025-03492-3. | |
| 39384087 | Derived | Lane HY, Wang SH, Lin CH. Sex- and dose-dependent catalase increase and its clinical impact in a benzoate dose-finding, randomized, double-blind, placebo-controlled trial for Alzheimer's disease. Pharmacol Biochem Behav. 2024 Dec;245:173885. doi: 10.1016/j.pbb.2024.173885. Epub 2024 Oct 9. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Drug |
DAOI with B dose |
|
| DAOI-C group | Drug | DAOI with C dose |
|
| Placebo oral capsule | Drug | Placebo |
|
Cognitive assessment
| week 0, 24 |
| Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24 | Cognitive assessment | week 0, 24 |
| Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24 | Cognitive assessment | week 0, 24 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |