NMDA Enhancement Combined With Omega-3 for Early Dementia

Chang Gung Medical Foundation

Status and phase: Not yet enrolling; Phase 2

Conditions: Dementia; Omega 3 Fatty Acids

Treatments: Drug: DAOIB+Omega-3; Drug: DAOIB+Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05181189

111-0510163

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

DAOIB+Omega-3

Experimental group

Treatment:

Drug: DAOIB+Omega-3

DAOIB+Placebo

Placebo Comparator group

Treatment:

Drug: DAOIB+Placebo