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The Dose Finding Study of DAOIB Added to tDCS for AD

Primary Purpose

Transcranial Direct Current Stimulation, Dementia

Status

Suspended

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

DAOIB

About this trial

This is an interventional treatment trial for Transcranial Direct Current Stimulation

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

tDCS+Dose A

tDCS+Dose B

tDCS+Dose C

tDCS+placebo

Arm Description

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

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

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

Drug: Placebo Placebo Device: tDCS tDCS

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26

Change from baseline in Mini-Mental Status examination score at week 10, 18 and 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

The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)

Change from baseline in Quality of life score at week 10, 18 and 26

Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.

Change from baseline in the composite score of a battery of additional cognitive tests at week 26

The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing).

Full Information

NCT ID

NCT05006781

First Posted

August 9, 2021

Last Updated

October 13, 2022

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05006781

Brief Title

The Dose Finding Study of DAOIB Added to tDCS for AD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Suspended

Why Stopped

The trial was suspended due to the COVID-19 pandemic

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

August 19, 2025 (Anticipated)

Study Completion Date

August 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transcranial Direct Current Stimulation, Dementia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tDCS+Dose A

Arm Type

Experimental

Arm Description

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

Arm Title

tDCS+Dose B

Arm Type

Experimental

Arm Description

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

Arm Title

tDCS+Dose C

Arm Type

Experimental

Arm Description

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

Arm Title

tDCS+placebo

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo Placebo Device: tDCS tDCS

Intervention Type

Drug

Intervention Name(s)

DAOIB

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 10, 18 and 26

Description

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

Time Frame

week 0, 10, 18, 26

Secondary Outcome Measure Information:

Title

Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26

Description

Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26

Time Frame

week 10, 18, 26

Title

Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26

Description

Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26

Time Frame

week 0, 10, 18, 26

Title

Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 10, 18 and 26

Description

The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)

Time Frame

week 0, 10, 18, 26

Title

Change from baseline in Quality of life score at week 10, 18 and 26

Description

Time Frame

week 0, 10, 18, 26

Title

Change from baseline in the composite score of a battery of additional cognitive tests at week 26

Description

Time Frame

week 0, 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of Alzheimer's disease or mild cognitive impairment MMSE between 10-26 CDR 1 or 0.5 Exclusion Criteria: 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

Facility Information:

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

886

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Dose Finding Study of DAOIB Added to tDCS for AD

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