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This open-label clinical trial will enroll patients with aMCI or mild AD, and they will be treated with DAOIB for 24 weeks. We will assess the patients before entering the study, 8 weeks, 16 weeks, and end point (24 weeks) of the study, and measure blood NMDA and oxidative stress - related biomarkers every 8 weeks. We hypothesize that NMDA and oxidative stress - related biomarkers can predict the efficacy of DAOIB for patients with aMCI or mild AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAOIB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOIB | Drug | The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation. |
|
| 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 scores range from 0 (best) to 70 (worst) | week 0, 8, 16, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the composite score of a battery of additional cognitive tests at week 24 | The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing) | week 0, 24 |
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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 |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 |
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 |
| 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 | The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best) | week 0, 8, 16, 24 |
| Change from baseline of Geriatric Depression Scale | Assessment of geriatric depressive symptoms | week 0, 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 |
| China Medical University Hospital | Recruiting | Taichung | Taiwan |
|
| D001523 | Mental Disorders |