DAOIB for the Treatment of Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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DAOIB for the Treatment of Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Drug: DAOIB
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of mild cognitive impairment MMSE between 17-26 CDR 0.5 Exclusion Criteria: Hachinski Ischemic Score > 4 Substance abuse/dependence Parkinson disease, epilepsy, dementia with psychotic features Major psychiatric disorders 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAOIB<br>oral, for 24 weeks | Drug: DAOIB<br>* oral, for 24 weeks<br>|
| Placebo Comparator: Placebo<br>oral, for 24 weeks | Drug: Placebo<br>* oral, for 24 weeks<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 consists of 11 tasks. Its 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 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. | 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 |