NCT05181189

NMDA Enhancement Combined With Omega-3 for Early Dementia

NMDA Enhancement Combined With Omega-3 Fatty Acids for the Treatment of Early Dementia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	DAOIB+Omega-3	The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
DRUG	DAOIB+Placebo	Placebo

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2022-01-06
• Last updated: 2026-03-20

Locations

1 site across 1 country: Taiwan