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Completed

NCT Number: NCT03369925

Cognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment

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.

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Key information

Conditions

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis Clinical Research, Inc.

Addison, Illinois, 60101, United States

About this study

This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women with Age-Associated Memory Impairment. Cognitive assessments will be performed to determine whether citicoline administration with supportive memory, compared to placebo administration.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo supplement

Dietary Supplement

Cellulose

Other names: Placebo

Citicoline supplement

Dietary Supplement

Cognizin

Other names: Cognizin

Primary outcomes

  1. Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Hakko Bio Co., Ltd.

Industry

Collaborators

  • Biofortis Clinical Research, Inc.

Registry information

Official study title

A Parallel, Double-Blind Study to Assess the Cognitive Effects of a Citicoline Supplement (Cognizin®) in Men and Women With Age-Associated Memory Impairment

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2017
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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