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Efficacy Biomarkers of DAOIB for Dementia

Primary Purpose

Dementia

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DAOIB
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

50 Years - 90 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

  • Chang Gung Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAOIB

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change from baseline in the composite score of a battery of additional cognitive tests at week 24
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)
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 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
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 of Geriatric Depression Scale
Assessment of geriatric depressive symptoms
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

Full Information

First Posted
October 13, 2022
Last Updated
May 19, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05582161
Brief Title
Efficacy Biomarkers of DAOIB for Dementia
Official Title
Efficacy Biomarkers of DAOIB for Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This open-label clinical trial will enroll patients with aMCI or mild AD, and they will be treated with DAOIB for 24 weeks. We will assess the patients before entering the study, 8 weeks, 16 weeks, and end point (24 weeks) of the study, and measure blood NMDA and oxidative stress - related biomarkers every 8 weeks. We hypothesize that NMDA and oxidative stress - related biomarkers can predict the efficacy of DAOIB for 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
Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAOIB
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DAOIB
Intervention Description
The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.
Primary Outcome Measure Information:
Title
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Description
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)
Time Frame
week 0, 8, 16, 24
Secondary Outcome Measure Information:
Title
Change from baseline in the composite score of a battery of additional cognitive tests at week 24
Description
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)
Time Frame
week 0, 24
Title
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Description
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Time Frame
week 8, 16, 24
Title
Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
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, 8, 16, 24
Title
Change from baseline of Geriatric Depression Scale
Description
Assessment of geriatric depressive symptoms
Time Frame
week 0, 8, 16, 24
Title
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
Description
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
Time Frame
week 0, 8, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chieh-Hsin Lin, MD, PhD
Phone
886-7-7317123
Ext
8907
Email
cyndi36@gmail.com
First Name & Middle Initial & Last Name & Degree
Chieh-Hsin Lin, MD, PhD
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Yuan Lane, MD, PhD
Phone
886-4-22052121
Email
hylane@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy Biomarkers of DAOIB for Dementia

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