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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
The DAOIB dose in each group will be fixed during the 24 weeks duration
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
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)
Time frame: week 0, 10, 18, 26
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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: week 0, 26
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