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Not Yet Recruiting NCT05181189

NMDA Enhancement Combined With Omega-3 for Early Dementia

Conditions: Omega 3 Fatty Acids, Dementia

Sex: All
Ages: 50 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 140
Sponsor: Chang Gung Memorial Hospital

Location: Kaohsiung Chang Gung Memorial Hospital Kaohsiung City

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 Criteria

Inclusion Criteria: * Clinical diagnosis of Alzheimer's disease or mild cognitive impairment * MMSE between 10-26 * CDR 1 or 0.5 Exclusion Criteria: * Hachinski Ischemic Score \> 4 * Substance abuse/dependence * Parkinson disease, epilepsy, dementia with psychotic features * Major depressive disorder * Major physical illnesses * memantine or special omega-3 fatty acids therapy within 3 months before enrollment * Severe visual or hearing impairment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05181189). StuddyBuddy aggregates publicly available trial information.