Omega 3 Fatty AcidsPhase 2NCT05181189
NMDA Enhancement Combined With Omega-3 for Early Dementia
A Phase 2 study testing DAOIB+Omega-3 in people with Omega 3 Fatty Acids and Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 +… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Omega 3 Fatty Acids, Dementia
- What is being tested?
- DAOIB+Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2027to Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
- MMSE between 10-26
- CDR 1 or 0.5
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: NMDA Enhancement Combined With Omega-3 Fatty Acids for the Treatment of Early Dementia
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
- Omega 3 Fatty Acids, Dementia
- Being tested
- DAOIB+Omega-3, DAOIB+Placebo
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAOIB+Omega-3Drug
The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
DAOIB+PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DAOIB+Omega-3 | Experimental | Not described Receives: Drug: DAOIB+Omega-3 |
| DAOIB+Placebo | Placebo comparator | Not described Receives: Drug: DAOIB+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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).
Measured: week 0, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omega 3 Fatty AcidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181189
- Sponsor's protocol ID
- 111-0510163
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No