NMDA Enhancement Combined With Omega-3 for Early Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DAOIB+Omega-3, DAOIB+Placebo.
- Who it may be relevant to
- Registry conditions: Omega 3 Fatty Acids, Dementia. Basic parameters: 50 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NMDA Enhancement Combined With Omega-3 Fatty Acids for the Treatment of Early Dementia
Overview
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.
Interventions
- Drug DAOIB+Omega-3
The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation. - Drug DAOIB+Placebo
Placebo
Primary outcome measures
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
Secondary outcome measures (6)
- Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 [Time frame: week 8, 16, 24]
- Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
- Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 8, 16 and 24 [Time frame: 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 [Time frame: week 0, 8, 16, 24]
- Change from baseline in Quality of life score at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
- Change from baseline in the composite score of a battery of additional cognitive tests at week 24 [Time frame: week 0, 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT05181189 · 111-0510163