NCT05006781

The Dose Finding Study of DAOIB Added to tDCS for AD

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcranial Direct Current Stimulation
• Dementia

Interventions

Type	Name	Description
DRUG	DAOIB	The DAOIB dose in each group will be fixed during the 24 weeks duration

Timeline

• Start date: 2027-01-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2021-08-16
• Last updated: 2026-03-20

Locations

1 site across 1 country: Taiwan