The Dose Finding Study of DAOIB Added to tDCS for AD

Study Overview
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Brief Summary
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This is a 26-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 4 treatment groups for 24 weeks: (1) Dose A group; (2) Dose B group; (3) Dose C group; (4) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 10, 18, and 26). We hypothesize that augmentation with certain dose of DAOIB will yield better effect than tDCS alone in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.

Official Title
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The Dose Finding Study of Sodium Benzoate Added to tDCS for the Treatment of Early-phase Alzheimer's Disease

Conditions
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Transcranial Direct Current Stimulation, 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: 100 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: tDCS+Dose A<br>Drug: DAOIB at dose A The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS | Drug: DAOIB<br>* The DAOIB dose in each group will be fixed during the 24 weeks duration<br>|
| Experimental: tDCS+Dose B<br>Drug: DAOIB at dose B The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS | Drug: DAOIB<br>* The DAOIB dose in each group will be fixed during the 24 weeks duration<br>|
| Experimental: tDCS+Dose C<br>Drug: DAOIB at dose C The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS | Drug: DAOIB<br>* The DAOIB dose in each group will be fixed during the 24 weeks duration<br>|
| Placebo Comparator: tDCS+placebo<br>Drug: Placebo Placebo Device: tDCS tDCS | Drug: DAOIB<br>* The DAOIB dose in each group will be fixed during the 24 weeks duration<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 10, 18 and 26 | Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst) | week 0, 10, 18, 26 | 

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 10, 18 and 26 | Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26 | week 10, 18, 26 | 
| Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26 | Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26 | week 0, 10, 18, 26 | 
| Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 10, 18 and 26 | 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, 10, 18, 26 | 
| Change from baseline in Quality of life score at week 10, 18 and 26 | Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health. | week 0, 10, 18, 26 | 
| Change from baseline in the composite score of a battery of additional cognitive tests at week 26 | 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, 26 |