NMDA Enhancement Combined With Omega-3 for Early Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Omega 3 Fatty Acids Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DAOIB+Omega-3

Group Type EXPERIMENTAL

DAOIB+Omega-3

Intervention Type DRUG

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

DAOIB+Placebo

Group Type PLACEBO_COMPARATOR

DAOIB+Placebo

Intervention Type DRUG

Placebo

Interventions

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DAOIB+Omega-3

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

Intervention Type DRUG

DAOIB+Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No