NCT03444662

Brief Summary

The goal of this study is to determine the effects of Citicoline plus Omega-3 or Omega-3 alone versus placebo on attention in non-demented healthy older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
Last Updated

September 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

February 14, 2018

Last Update Submit

September 9, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Accuracy (percent correct) on an attention task (Conners continuous performance test3)

    16 weeks

Secondary Outcomes (1)

  • Scores of Neuropsychological test battery from the Uniform Data Set

    16 weeks

Other Outcomes (3)

  • Number of participants with treatment-related adverse events as monitored by recording a comprehensive metabolic panel, complete blood count and prothrombin time-international normalized ratio

    16 weeks

  • Plasma fatty acid levels

    16 weeks

  • Apolipoprotein E genotype

    Baseline

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Intervention: Dietary Supplement: Placebo supplement

Dietary Supplement: Placebo supplement

Cognizin and Omega-3

EXPERIMENTAL

Intervention: Dietary Supplement: Citicoline and Omega-3 supplement

Dietary Supplement: Citicoline and Omega-3 supplement

Omega-3

EXPERIMENTAL

Intervention: Dietary Supplement: Omega-3 supplement

Dietary Supplement: Omega-3 supplement

Interventions

Placebo supplementDIETARY_SUPPLEMENT

Cellulose and Sunflower oil

Also known as: Placebo
Placebo
Citicoline and Omega-3 supplementDIETARY_SUPPLEMENT

Citicoline and Omega-3

Also known as: Cognizin and Omega-3
Cognizin and Omega-3
Omega-3 supplementDIETARY_SUPPLEMENT

Cellulose and Omega-3

Also known as: Omega-3
Omega-3

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 years or older
  • If female, must be post-menopausal
  • Non-demented
  • Not depressed
  • General health status that will not interfere with the participant's ability to complete the study
  • No history of neurological disorder
  • Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
  • Sufficient English language skills to complete all testing

You may not qualify if:

  • Alzheimer's, Dementia or other neurological disease
  • Fish intake of 6 ounce serving once a week 3 months prior to enrollment; Omega-3 supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 3 months prior to enrollment.
  • Citicoline supplementation 3 months prior to enrollment
  • Prescriptions medications:
  • Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven), Factor Xa inhibitors: rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis); Low molecular weight heparins: dalteparin (fragmin), enoxaparin (lovenox)
  • Dementia medications (e.g. anticholinesterase inhibitors, memantine)
  • Diagnosis of Adult Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD) and/or taking stimulants (e.g. dextroamphetamine sulfate, methylphenidate HCL, dextroamphetamine Sulf-Saccharate)
  • Body Mass Index \> 30
  • Enrollment in another treatment study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Cytidine Diphosphate CholineDocosahexaenoic Acids

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 23, 2018

Study Start

June 12, 2018

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

September 10, 2019

Record last verified: 2019-04

Locations

US(1)