NMDA Enhancement Combined With Omega-3 for Early Dementia

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT05181189
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Dementia
  • Omega 3 Fatty Acids

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 6, 2022
Start date
Aug 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DAOIB+Omega-3
  • Placebo Comparator: DAOIB+Placebo

Primary Outcome Measure

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 ]

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