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NCT Number: NCT05582161

Efficacy Biomarkers of DAOIB for Dementia

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAOIB

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. Change from baseline of Geriatric Depression Scale

    Time frame: week 0, 8, 16, 24

    Assessment of geriatric depressive symptoms

  5. 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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