NCT03369925

Brief Summary

The objective of this trial is to determine the effects of citicoline on cognitive performance in healthy Men and Women with Age-Associated Memory Impairment compared to a placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2018

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

December 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

December 7, 2017

Last Update Submit

February 25, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo supplement

Cognizin

EXPERIMENTAL
Dietary Supplement: Citicoline supplement

Interventions

Placebo supplementDIETARY_SUPPLEMENT

Cellulose

Also known as: Placebo
Placebo
Citicoline supplementDIETARY_SUPPLEMENT

Cognizin

Also known as: Cognizin
Cognizin

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female, 50-85 years of age
  • at least a high school diploma or the equivalent
  • self-reported memory loss
  • scores ≥24 on the Mini-Mental State Examination, ≥85 on the Kaufman Brief Intelligence Test, Second Edition, ≤5 on the Geriatric Depression Scale, and 4, 3, or 2 on the Spatial Span Test
  • no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results

You may not qualify if:

  • color blind
  • abnormal laboratory test results
  • major medical or neurological illness
  • female who is pregnant, planning to be pregnant during the study period
  • requiring treatment with a drug which might obscure the action of the study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis Clinical Research, Inc.

Addison, Illinois, 60101, United States

Location

Related Publications (1)

  • Nakazaki E, Mah E, Sanoshy K, Citrolo D, Watanabe F. Citicoline and Memory Function in Healthy Older Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Nutr. 2021 Aug 7;151(8):2153-2160. doi: 10.1093/jn/nxab119.

    PMID: 33978188DERIVED

Study Design

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

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

January 2, 2018

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)