Novel Augmentation of DAOIB and Antioxidant for Early Dementia
NCT Number: NCT06467539
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alzheimer Disease|Mild Cognitive Impairment
Interventions: DRUG: DAOIB plus AO|DRUG: DAOIB plus placebo
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2027-05
Locations: Chang Gung Memorial Hospital, Kaohsiung, 886, Taiwan

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.

Primary Outcome Measures: 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: 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 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 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 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 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