Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, Omega-3 fatty acid, Dietary supplementation, Cognition, Safety
Brief summary
Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in AD patients
Interventions
DRUGEPAX 1050TG
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Alzheimer's disease with MMSE 15-30, living in own homes, treated with stable dose of acetylcholine esterase inhibitor for \>3 months and remaining on that treatment for the study period
Exclusion criteria
Already treated with omega-3 fatty acids, NSAIDs, warfarin, being an alcohol abuser, suffering from serious concomitant disease or not having a caregiver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition measured according to ADAS-cog, MMSE scales | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, tolerability, blood pressure | — | — |
| Gene expression | 2007-2018 | mRNA expression and DNA methylation changes in blood leukocytes in relation to changes of plasma and cerebrospinal concentrations of omega-3 fatty acids |
| Dose-response studies in relation to APOE4 status, to body weight and to gender | 2007-2018 | Analysis of changes of plasma and cerebrospinal fluid concentrations of omega-3 fatty acids in relation to APOE4 status, body weight and gender, as well as to changes in ADAS-cog and MMSE as measures of cognition. |
Countries
Sweden
Outcome results
None listed