Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Phase 2

Recruiting

• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Drug: DAOIB plus placebo; Drug: DAOIB plus AO

• Registration Number: NCT06467539
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-16
• Study First Submitted QC: 2024-06-16
• Study Start: 2024-06-19
• Study First Posted: 2024-06-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	DAOIB plus placebo	DAOIB plus Placebo
Experimental	DAOIB plus AO	DAOIB plus Antioxidant agent (AO)

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 consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24	week 0, 8, 16, 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.
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	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).
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	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.
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
Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24	week 0, 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).
Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24	week 0, 8, 16, 24	The SF-36 consists of eight sections which assess the quality of life.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan