NMDA Enhancement Combined With Omega-3 for Early Dementia
NCT05181189 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2026-03-20
Summary
In this 4-year proposed project, we will enroll 140 patients with aMCI or mild AD into a 24-week randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to one of two treatment groups for 24 weeks (n = 70 in each group) in a double-blind manner: \[1\] DAOIB + omega-3; \[2\] DAOIB + placebo. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB combined with omega-3 will yield better efficacy than placebo in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.
Conditions
- Omega 3 Fatty Acids
- Dementia
Interventions
- DRUG
-
DAOIB+Omega-3
The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
- DRUG
-
DAOIB+Placebo
Placebo
Sponsors & Collaborators
-
Chang Gung Memorial Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-03-31
- Completion
- 2028-03-31
Countries
- Taiwan
Study Locations
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