NCT04737096

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 27, 2021

Last Update Submit

January 4, 2023

Conditions

Transcranial Direct Current StimulationDementia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

    Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

    week 0, 8, 16, 24

Secondary Outcomes (5)

  • Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

    week 8, 16, 24

  • Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

    week 0, 8, 16, 24

  • Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

    week 0, 8, 16, 24

  • Change from baseline in Quality of life score at week 8, 16 and 24

    week 0, 8, 16, 24

  • Change from baseline in the composite score of a battery of additional cognitive tests at week 24

    week 0, 24

Study Arms (2)

tDCS+DAOIB

EXPERIMENTAL
Drug: DAOIBDevice: tDCS

tDCS+placebo

PLACEBO COMPARATOR
Drug: PlaceboDevice: tDCS

Interventions

DAOIBDRUG

The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.

tDCS+DAOIB
PlaceboDRUG

placebo

tDCS+placebo
tDCSDEVICE

tDCS

tDCS+DAOIBtDCS+placebo

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

MeSH Terms

Conditions

Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

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

January 27, 2021

First Posted

February 3, 2021

Study Start

January 1, 2020

Primary Completion

January 2, 2023

Study Completion

January 2, 2023

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)