Efficacy Biomarkers of DAOIB for Dementia

Phase 2

Recruiting

• Conditions: Dementia
• Interventions: Drug: DAOIB

• Registration Number: NCT05582161
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DAOIB	DAOIB	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the composite score of a battery of additional cognitive tests at week 24	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)
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 Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 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	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)
Change from baseline of Geriatric Depression Scale	week 0, 8, 16, 24	Assessment of geriatric depressive symptoms
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24	week 0, 8, 16, 24	Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

Trial Locations

Locations (2)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan