NCT05582161

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P75+ for phase_2

Timeline
4mo left

Started Oct 2022

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Oct 2022Sep 2026

Study Start

First participant enrolled

October 3, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

October 13, 2022

Last Update Submit

March 18, 2026

Conditions

Dementia

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 the composite score of a battery of additional cognitive tests at week 24

    week 0, 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 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 of Geriatric Depression Scale

    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

Study Arms (1)

DAOIB

EXPERIMENTAL
Drug: DAOIB

Interventions

DAOIBDRUG

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

DAOIB

Eligibility Criteria

Age50 Years - 90 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 (2)

Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 17, 2022

Study Start

October 3, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)