NCT04737096

DAOIB Combined With tDCS for Early-phase Dementia

DAOIB Combined With tDCS for Early-phase Dementia - a Randomized, Double-blinded and Placebo Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a 24-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 2 treatment groups for 24 weeks: (1) DAOIB group; (2) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that augmentation with 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 will be adjusted every 8 weeks according to clinical evaluation.
DRUG	Placebo	placebo
DEVICE	tDCS	tDCS

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-01-02
• Completion: 2023-01-02
• First posted: 2021-02-03
• Last updated: 2023-01-06

Locations

1 site across 1 country: Taiwan