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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
Sponsor:
Collaborators:
BASF AS
Pre Diagnostics AS
Information provided by (Responsible Party):
Nora Christine Lund Sørbøe, University Hospital, Akershus

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Cognitive function [ Time Frame: Baseline to 24 weeks ]
CERAD 10 word memory test relative to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Dose Omega 3 in People at Risk for Dementia
Official Title  ICMJE A Randomized, 24 Week Parallel-group Placebo-controlled (Phase 2) Pilot-study of High Dose Omega 3 (DHA) in People at Risk for Dementia
Brief Summary 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).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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
Primary Purpose: Prevention
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Olive oil
    Soft gelatine capsule containing 1000 mg olive oil, refined.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Olive oil
  • 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.
    Intervention: Dietary Supplement: Omega-3 capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926351
Other Study ID Numbers  ICMJE REC: 2017/1364
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nora Christine Lund Sørbøe, University Hospital, Akershus
Study Sponsor  ICMJE University Hospital, Akershus
Collaborators  ICMJE
  • BASF AS
  • Pre Diagnostics AS
Investigators  ICMJE
Principal Investigator: Tormod Fladby, MD PhD University Hospital, Akershus
PRS Account University Hospital, Akershus
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP