Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Drug: DAOIB plus AO; Drug: DAOIB plus placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 886
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Chieh-Hsin Lin, MD, PhD; Phone Number: 8753 886-7-7317123; Email: cyndi36@gmail.com
    • Principal Investigator: Chieh-Hsin Lin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; DAOIB plus Antioxidant agent (AO)	Drug: DAOIB plus AO; oral, for 24 weeks
Placebo Comparator: Placebo Comparator; DAOIB plus Placebo	Drug: DAOIB plus placebo; oral, for 24 weeks

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	Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its 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 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	week 0, 8, 16, 24
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24	Clinician's Interview-Based Impression of Change plus Caregiver Input score is a global assessment of change based on a comprehensive, semi-structured interview which includes caregiver-supplied information. It is a 7-point rating scale ranging from 1-7, where 1 represents markedly improved; 4, no change; and 7, markedly worse.	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	ADCS-MCI-ADL appears to be a suitable instrument for evaluating activities of daily living in mild cognitive impairment. Its scores range from 0 (worst) to 78 (best).	week 0, 8, 16, 24
Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24	The SF-36 consists of eight sections which assess the quality of life.	week 0, 8, 16, 24
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24	Clinical Dementia Rating Scale (CDR) is a global assessment tool that yields global and Sum of Boxes scores (SB). Compared to the global CDR score, the CDR-SB score provides better utility in tracking changes in dementia severity.	week 0, 8, 16, 24
Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24	The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (verbal and nonverbal, Wechsler Memory Scale), learning and memory tests (verbal and visual, Wechsler Memory Scale).	week 0, 24

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: 202200458A3C502

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