Efficacy Biomarkers of DAOIB for Dementia

February 6, 2024 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 886
        • Recruiting
        • Chang Gung Memorial Hospital
        • Principal Investigator:
          • Chieh-Hsin Lin, MD, PhD
        • Contact:
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAOIB
Drug: DAOIB
The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Time Frame: week 0, 8, 16, 24
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)
week 0, 8, 16, 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: week 0, 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
Time Frame: week 0, 8, 16, 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)
week 0, 8, 16, 24
Change from baseline in the composite score of a battery of additional cognitive tests at week 24
Time Frame: week 0, 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)
week 0, 24
Change from baseline of Geriatric Depression Scale
Time Frame: week 0, 8, 16, 24
Assessment of geriatric depressive symptoms
week 0, 8, 16, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101070A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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