Efficacy Biomarkers of DAOIB for Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Biomarkers of DAOIB for Dementia

Conditions
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Dementia

Intervention / Treatment
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* Drug: DAOIB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Alzheimer's disease or mild cognitive impairment MMSE between 10-26 CDR 1 or 0.5 Exclusion Criteria: Hachinski Ischemic Score > 4 Substance abuse/dependence Parkinson disease, epilepsy, dementia with psychotic features Major depressive disorder Major physical illnesses Severe visual or hearing impairment

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAOIB<br> | Drug: DAOIB<br>* The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |