NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
Overview
- Phase
- Phase 2
- Intervention
- DAOI-C group
- Conditions
- Alzheimer Disease
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of Alzheimer's disease
- •MMSE between 10-26
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
DAOI-C group
Intervention: DAOI-C group
Placebo group
Intervention: Placebo oral capsule
DAOI-A group
Intervention: DAOI-A group
DAOI-B group
Intervention: DAOI-B group
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
Cognitive assessment
Secondary Outcomes
- Change from baseline in speed of processing (Category Fluency) at week 24(week 0, 24)
- Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24(week 0, 24)
- Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24(week 8, 16, 24)
- Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24(week 0, 24)