The Dose Finding Study of Sodium Benzoate Added to tDCS for the Treatment of Early-phase Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 10, 18 and 26
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
tDCS+Dose A
Drug: DAOIB at dose A The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS
Intervention: DAOIB (Drug)
tDCS+Dose B
Drug: DAOIB at dose B The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS
Intervention: DAOIB (Drug)
tDCS+Dose C
Drug: DAOIB at dose C The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS
Intervention: DAOIB (Drug)
tDCS+placebo
Drug: Placebo Placebo Device: tDCS tDCS
Intervention: DAOIB (Drug)
Outcomes
Primary Outcomes
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 10, 18 and 26
Time Frame: week 0, 10, 18, 26
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)
Secondary Outcomes
- 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 Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 10, 18 and 26(week 0, 10, 18, 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 the composite score of a battery of additional cognitive tests at week 26(week 0, 26)
- Change from baseline in Quality of life score at week 10, 18 and 26(week 0, 10, 18, 26)