Dementia Clinical Trial
Official title:
A Randomized, 24 Week Parallel-group Placebo-controlled (Phase 2) Pilot-study of High Dose Omega 3 (DHA) in People at Risk for Dementia
The aim of this study is the efficacy of a docosahexaenoic acid (DHA)-rich dietary supplement in improving key dementia-related mechanisms and cognitive function in older people at risk for dementia. This is a randomized placebo-controlled, 24 weeks, phase 2 study of Omega 3 in people with increased risk of dementia. The aim is to explore the effects of DHA on cognitive performance (CERAD 10 word memory tests, TMT A/B, Stroop Color-Word, FAS, VOSP silhouettes, Cantab-test (RT, PAL, SWT)), biological markers (blood: CRP, NLF, TNF-alpha, MCI-1, PBMC Abeta middomain, Omega-3-index, IL, CSF: NLF, sTREM2, Ab 1-42, total and -phospho-tau) and imaging (MRI: standard structural DDI protocol including Freesurfer and WML measurements, DTI and ASL).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 2020 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 79 Years |
Eligibility |
Inclusion Criteria: - Age > 50 years - SCD or MCI - No evidence of neurodegeneration (i.e. CSF phospho and total tau-levels below cut-off) - Scandinavian mother tongue - Completed 2-year follow-up in the DDI-study - Stable medication for at least 3 months prior to baseline exam Exclusion Criteria: - Dementia (defined as MMSE < 26 and/or CDR >/= 1)) - Other dementia giving disease than AD - Other brain disease - Significant depression - Unstable coronary heart disease or heart failure in need of treatment - Systemic inflammatory diseases - Somatic disease that might affect cognitive function adversely - Usage of anticoagulants - Prior radiation- or chemo-therapy possibly affecting CNS - Relevant cancer or other serious disease with expected survival < 5 years - Fish meal intake more than 2 times a week - Regularly intake of Omega-3 supplements over the last 3 months |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus university hospital, Sykehusveien 25 | Lørenskog |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | BASF AS, Pre Diagnostics AS |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive function | CERAD 10 word memory test relative to placebo | Baseline to 24 weeks | |
Secondary | Cognitive function | Cantab RT test relative to placebo | Baseline to 24 weeks | |
Secondary | Cognitive function | Cantab PAL test relative to placebo | Baseline to 24 weeks | |
Secondary | Cognitive function | Cantab SWT test relative to placebo | Baseline to 24 weeks | |
Secondary | Blood PBMC betaAmyloid mid-domain assay | IVD assay | Baseline to 24 weeks | |
Secondary | CSF betaAmyloid 1-42 | IVD assay | Baseline to 24 weeks | |
Secondary | CSF TAU | IVD assay | Baseline to 24 weeks | |
Secondary | CSF Phospho-TAU | IVD assay | Baseline to 24 weeks | |
Secondary | MRI ASL | MRI procedure | Baseline to 24 weeks | |
Secondary | MRI WML | MRI procedure | Baseline to 24 weeks | |
Secondary | MRI DTI | MRI procedure | Baseline to 24 weeks |
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