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The Dose Finding Study of DAOIB Added to tDCS for AD

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05006781
Collaborator
(none)
140
Enrollment
1
Location
4
Arms
41.6
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Dose Finding Study of Sodium Benzoate Added to tDCS for the Treatment of Early-phase Alzheimer's Disease
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Aug 19, 2025
Anticipated Study Completion Date :
Aug 19, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: tDCS+Dose A

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

Drug: DAOIB
The DAOIB dose in each group will be fixed during the 24 weeks duration
Experimental: tDCS+Dose B

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

Drug: DAOIB
The DAOIB dose in each group will be fixed during the 24 weeks duration
Experimental: tDCS+Dose C

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

Drug: DAOIB
The DAOIB dose in each group will be fixed during the 24 weeks duration
Placebo Comparator: tDCS+placebo

Drug: Placebo Placebo Device: tDCS tDCS

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 10, 18 and 26 [week 0, 10, 18, 26]

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

Secondary Outcome Measures

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

  2. Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26 [week 0, 10, 18, 26]

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

  3. 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]

    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)

  4. Change from baseline in Quality of life score at week 10, 18 and 26 [week 0, 10, 18, 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.

  5. Change from baseline in the composite score of a battery of additional cognitive tests at week 26 [week 0, 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 886

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05006781
Other Study ID Numbers:
  • 202002208A0
First Posted:
Aug 16, 2021
Last Update Posted:
Dec 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dementia

Study Results

No Results Posted as of Dec 16, 2021