NCT04737096

DAOIB Combined With tDCS for Early-phase Dementia

Completed Phase 2 Last updated 6 January 2023

What this trial tests

Phase 2 trial testing DAOIB in Transcranial Direct Current Stimulation in 97 participants. Completed in 2 January 2023.

Timeline

1 January 2020

Primary endpoint
2 January 2023

2 January 2023

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	97
Start date	1 January 2020
Primary completion	2 January 2023
Estimated completion	2 January 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• DAOIB — full drug profile →
• Placebo
• tDCS — full drug profile →

Conditions studied

• Transcranial Direct Current Stimulation — all drugs for Transcranial Direct Current Stimulation →
• Dementia — all drugs for Dementia →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 50 to 100, any sex, with Transcranial Direct Current Stimulation or Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.