NMDA Enhancement Combined With Omega-3 for Early Dementia

NCT05181189 | Not Yet Recruiting Phase 2

• 1 other identifier: 111-0510163
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Omega 3 Fatty Acids

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

  Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

  week 0, 8, 16, 24

Secondary Outcomes (6)

• Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

  week 8, 16, 24

• Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

  week 0, 8, 16, 24

• Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 8, 16 and 24

  week 0, 8, 16, 24

• Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

  week 0, 8, 16, 24

• Change from baseline in Quality of life score at week 8, 16 and 24

  week 0, 8, 16, 24

Study Arms (2)

DAOIB+Omega-3

EXPERIMENTAL

Drug: DAOIB+Omega-3

DAOIB+Placebo

PLACEBO COMPARATOR

Drug: DAOIB+Placebo

Interventions

DAOIB+Placebo DRUG

Placebo

DAOIB+Placebo

DAOIB+Omega-3 DRUG

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

DAOIB+Omega-3

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
• MMSE between 10-26
• CDR 1 or 0.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 6, 2022
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)