The Dose Finding Study of DAOIB Added to tDCS for AD

NCT05006781 | Suspended Phase 2

• 1 other identifier: 202002208A0
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcranial Direct Current Stimulation; Dementia

Outcome Measures

Primary Outcomes (1)

• 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)

  week 0, 10, 18, 26

Secondary Outcomes (5)

• 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 Mini-Mental Status examination score at week 10, 18 and 26

  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

  week 0, 10, 18, 26

• Change from baseline in Quality of life 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

Study Arms (4)

tDCS+Dose A

EXPERIMENTAL

Drug: DAOIB at dose A The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS

Drug: DAOIB

tDCS+Dose B

EXPERIMENTAL

Drug: DAOIB at dose B The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS

Drug: DAOIB

tDCS+Dose C

EXPERIMENTAL

Drug: DAOIB at dose C The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS

Drug: DAOIB

tDCS+placebo

PLACEBO COMPARATOR

Drug: Placebo Placebo Device: tDCS tDCS

Drug: DAOIB

Interventions

DAOIB DRUG

The DAOIB dose in each group will be fixed during the 24 weeks duration

tDCS+Dose A; tDCS+Dose B; tDCS+Dose C; tDCS+placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
• MMSE between 10-26
• CDR 1 or 0.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)