Novel Augmentation of DAOIB and Antioxidant for Early Dementia
Overview
- Phase
- Phase 2
- Intervention
- DAOIB plus AO
- Conditions
- Alzheimer Disease
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental
DAOIB plus Antioxidant agent (AO)
Intervention: DAOIB plus AO
Placebo Comparator
DAOIB plus Placebo
Intervention: DAOIB plus placebo
Outcomes
Primary Outcomes
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Time Frame: 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 Outcomes
- 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 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 the composite score of a battery of additional cognitive tests at week 8, 16 and 24(week 0, 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)