High Dose Omega 3 in People at Risk for Dementia

NCT03926351 | Unknown Phase 2

• 1 other identifier: REC: 2017/1364
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  CERAD 10 word memory test relative to placebo

  Baseline to 24 weeks

Secondary Outcomes (10)

• Cognitive function

  Baseline to 24 weeks

• Cognitive function

  Baseline to 24 weeks

• Cognitive function

  Baseline to 24 weeks

• Blood PBMC betaAmyloid mid-domain assay

  Baseline to 24 weeks

• CSF betaAmyloid 1-42

  Baseline to 24 weeks

Study Arms (2)

Arm 1a; Placebo

PLACEBO COMPARATOR

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

Arm 2a; Omega-3 capsules

EXPERIMENTAL

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

Interventions

Omega-3 capsules DIETARY_SUPPLEMENT

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.

Arm 2a; Omega-3 capsules

Olive oil DIETARY_SUPPLEMENT

Soft gelatine capsule containing 1000 mg olive oil, refined.

Arm 1a; Placebo

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• BASF AS: collaborator
• Pre Diagnostics: collaborator

Study Sites (1)

Akershus university hospital, Sykehusveien 25

Lørenskog, 1478, Norway

RECRUITING

MeSH Terms

Conditions

Dementia; Inflammation; Cognitive Dysfunction; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Interventions

Docosahexaenoic Acids; Olive Oil

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tormod Fladby, MD PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tormod Fladby, MD PhD

CONTACT

+4792817764; tormod.fladby@medisin.uio.no

Erik Christensen, MD PhD

CONTACT

+4795939918; erik@pre-diagnostics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research fellow

Model Details: A randomized, 24-week parallel-group placebo-controlled (Phase 2) pilot-study of high dose Omega 3 (DHA) in people at risk for dementia

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 24, 2019
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

NO (1)