High Dose Omega 3 in People at Risk for Dementia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926351|
Recruitment Status : Unknown
Verified April 2019 by Nora Christine Lund Sørbøe, University Hospital, Akershus.
Recruitment status was: Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia Inflammation Mild Cognitive Impairment Cognitive Decline SCD Cognitive Dysfunction Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorder Cognition Disorders||Dietary Supplement: Omega-3 capsules Dietary Supplement: Olive oil||Phase 2|
Earlier trials with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been moderately promising, but these interventions often suffered from relatively low DHA concentrations. In this trial, the investigators will use a DHA-rich dietary supplement formulated using a self-microemulsifying delivery system to accelerate absorption.
Modification of innate immune activity has already been seen using DHA-rich supplements, and this type of intervention has been shown to ameliorate AD-associated PBMC profiles, and to be associated with improvements in cognition. DHA can cross the BBB, and the resulting CSF concentrations are associated with reduced CSF total tau levels indicating that DHA reduce neurodegeneration, ameliorate Abeta42 induced neuronal damage, and increase microglia Abeta phagocytosis. However, pre-clinical and pre-dementia intervention trials linked to biomarkers for the AD disease process is lacking, and therefore, stratification with respect to stage of disease process has not been performed.
Study cohort: subjects in this pilot study will be recruited from the Norwegian Dementia Disease Initiative (DDI) cohort. The DDI cohort consists of 600 participants with Subjective Cognitive Dedcline (SCD), Mild Cognitive Impairment (MCI) and normal control subjects that have been included at dementia centres across Norway during 2012-2016. Blood samples and cerebrospinal fluid (CSF) have been collected and are stored centrally at Ahus. A comprehensive and highly standarized clinical assessment program has been administered by trained raters (assessors). The investigators are currently performing 2-year follow-up evaluations. Genetic data including APOE-isoforms have been collected as have baseline and follow-up MRIs, PET scans (so far in Oslo and Bergen) and baseline CSF examinations (Ab, total-tau and phosphorus-tau). Cognitive assessments at baseline and follow-up include MMSE and Clinical Dementia Rating (CDR), CERAD 10 word memory test, Clock drawing test, Trail Making Test A and B, Verbal fluency test (FAS), visual recognition test (VOSP silhouettes), Stropp Coloraturas-Word. Data is assembled in a customised database (UiO secure server (TSD)), developed based on XNAT (http://www.xnat.org) and also connected to pipelines for image analysis. A selection from CANTAB MCI test battery including RTI (reaction time), PAL (paired associates learning test), and SWM (spatial working memory).
Study design: All subjects included in the intervention study will have completed 2-year follow-up in the DDI study prior to inclusion and will be on stable medication at least 3 months prior to baseline examinations. Based on the existing electronic CRF for DDI, social e-RCT-CRFs will be developed and programmed into the proprietary XNAT database. Patients fulfilling the inclusion criteria will be identified by a nurse at the memory outpatient clinics and will be given a short information letter regarding the study. Written consent will be asked for. Thereafter, a medical and neurological examination of the patient will be performed, including a medical history and medication use.
This initial pilot study is a minor feasibility study with 40 subjects randomised equally to either of 2 treatment groups for 24 weeks,
Omega-3 3 capsules/day Placebo 3 capsules/day
Each study participant will take 3 capsules in the morning for the 24-week study period. The study may be followed by a larger and statistical valid study. Patients will be randomized (by means of a computerized program) to identically appearing set of capsules with Omega-3 or placebo, 1:1 (produced by BASF AS).
Optional extension study: Participants will be offered another 24-week Omega-3 capsule supply after study end, and a follow-up assessment after 1 year will be conducted, comparing those with and without continuous Omega-3 treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, 24-week parallel-group placebo-controlled (Phase 2) pilot-study of high dose Omega 3 (DHA) in people at risk for dementia|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Double blinded|
|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|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Placebo Comparator: Arm 1a; Placebo
Valid for the first 24 weeks of the study. Arm 1a: placebo, soft gelatine capsule containing 1000 mg olive oil, refined.
Dietary Supplement: Olive oil
Soft gelatine capsule containing 1000 mg olive oil, refined.
Experimental: Arm 2a; Omega-3 capsules
Valid for the first 24 weeks of the study. Arm 2a; Omega-3, (1000 mg fill weight per capsule) containing omega-3 ethyl ester concentrate with a high proportion of DHA.
Dietary Supplement: Omega-3 capsules
BASF AS is the developer of the gelatine capsules containing Omega-3 ethyl ester from fish oil concentrate, as the dietary (nutritional) ingredient. The additional capsule fill ingredients are food additives permitted in food supplements according to Regulation (EC) No 1333/2008 on Food additives.
- Cognitive function [ Time Frame: Baseline to 24 weeks ]CERAD 10 word memory test relative to placebo
- Cognitive function [ Time Frame: Baseline to 24 weeks ]Cantab RT test relative to placebo
- Cognitive function [ Time Frame: Baseline to 24 weeks ]Cantab PAL test relative to placebo
- Cognitive function [ Time Frame: Baseline to 24 weeks ]Cantab SWT test relative to placebo
- Blood PBMC betaAmyloid mid-domain assay [ Time Frame: Baseline to 24 weeks ]IVD assay
- CSF betaAmyloid 1-42 [ Time Frame: Baseline to 24 weeks ]IVD assay
- CSF TAU [ Time Frame: Baseline to 24 weeks ]IVD assay
- CSF Phospho-TAU [ Time Frame: Baseline to 24 weeks ]IVD assay
- MRI ASL [ Time Frame: Baseline to 24 weeks ]MRI procedure
- MRI WML [ Time Frame: Baseline to 24 weeks ]MRI procedure
- MRI DTI [ Time Frame: Baseline to 24 weeks ]MRI procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926351
|Contact: Tormod Fladby, MD PhDemail@example.com|
|Contact: Erik Christensen, MD PhDfirstname.lastname@example.org|
|Akershus university hospital, Sykehusveien 25||Recruiting|
|Lørenskog, Norway, 1478|
|Contact: Tormod Fladby +4767960000 email@example.com|
|Principal Investigator:||Tormod Fladby, MD PhD||University Hospital, Akershus|