NMDA Enhancement Combined With Omega-3 for Early Dementia

Condition(s) studied

Investigational drug(s) / intervention(s)

DAOIB+Omega-3: The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.

DAOIB+Placebo: Placebo

Study 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.

Eligibility

Primary outcome measure(s)

• Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 — week 0, 8, 16, 24
  Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

Trial sites (1)

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