A Phase 2 interventional study of DAOIB+Omega-3 and DAOIB+Placebo in Omega 3 Fatty Acids and Dementia, sponsored by Chang Gung Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 140 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
Drug: DAOIB+Omega-3
Drug: DAOIB+Placebo
The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
Placebo
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)
Time frame: week 0, 8, 16, 24
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
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
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
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
The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)
Time frame: week 0, 8, 16, 24
Change from baseline in Quality of life score at week 8, 16 and 24
Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.
Time frame: week 0, 8, 16, 24
Change from baseline in the composite score of a battery of additional cognitive tests at week 24
The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing).
Time frame: week 0, 24
Plan to share: No
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital