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Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | DAOIB plus Antioxidant agent (AO) |
|
| Placebo Comparator | Placebo Comparator | DAOIB plus Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOIB plus AO | Drug | oral, for 24 weeks |
| |
| DAOIB plus 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 | Recruiting | Kaohsiung City | 886 | Taiwan |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Drug |
oral, for 24 weeks |
|
| week 8, 16, 24 |
| Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 | Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 | week 0, 8, 16, 24 |
| Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24 | Clinical Dementia Rating Scale (CDR) is a global assessment tool that yields global and Sum of Boxes scores (SB). Compared to the global CDR score, the CDR-SB score provides better utility in tracking changes in dementia severity. | week 0, 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 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |