Dementia, Omega 3 Fatty Acids
Conditions
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.
Interventions
DRUGDAOIB+Omega-3
The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
DRUGDAOIB+Placebo
Placebo
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 | week 0, 8, 16, 24 | Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 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 Mini-Mental Status examination score 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 | 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 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 | 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) |
| Change from baseline in Quality of life score at week 8, 16 and 24 | week 0, 8, 16, 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. |
| Change from baseline in the composite score of a battery of additional cognitive tests at week 24 | week 0, 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). |
Countries
Taiwan
Outcome results
None listed