Novel Augmentation of DAOIB and Antioxidant for Early Dementia

NCT06467539 | Recruiting Phase 2

• 1 other identifier: 202200458A3C502
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 Mini-Mental Status examination score at week 8, 16 and 24

  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

  week 0, 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

  week 0, 8, 16, 24

• Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24

  week 0, 8, 16, 24

Study Arms (2)

Experimental

EXPERIMENTAL

DAOIB plus Antioxidant agent (AO)

Drug: DAOIB plus AO

Placebo Comparator

PLACEBO COMPARATOR

DAOIB plus Placebo

Drug: DAOIB plus placebo

Interventions

DAOIB plus AO DRUG

oral, for 24 weeks

Experimental

DAOIB plus placebo DRUG

oral, for 24 weeks

Placebo Comparator

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
• MMSE between 10-26
• CDR 1 or 0.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)