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

A Parallel, Double-Blind Study to Assess the Cognitive Effects of a Citicoline Supplement (Cognizin®) 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo supplement; Dietary supplement: Citicoline supplement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo supplement; Cellulose; Other Names: Placebo
Experimental: Cognizin	Dietary supplement: Citicoline supplement; Cognizin; Other Names: Cognizin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment	12 weeks

Collaborators and Investigators

• Sponsor: Kyowa Hakko Bio Co., Ltd.
• Collaborators: Biofortis Clinical Research, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nootropic Agents; Cytidine Diphosphate Choline
• Other Study ID Numbers: BIO-1707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No