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

111-0510163

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.

2024-07-01

2027-06-01

2027-06-01

Not yet recruiting

Early phase I

140

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2024-02-07