Menu
Recruiting NCT05582161

Efficacy Biomarkers of DAOIB for Dementia

Phase II Interventional Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DAOIB.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Change from baseline in the composite score of a battery of additional cognitive tests at week 24 [Time frame: week 0, 24]
  • 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 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]
  • Change from baseline of Geriatric Depression Scale [Time frame: week 0, 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • Chang Gung Memorial Hospital — Kaohsiung City
  • China Medical University Hospital — Taichung

Identifiers

NCT: NCT05582161 · 202101070A3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗