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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369925
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Biofortis Clinical Research, Inc.
Information provided by (Responsible Party):
Kyowa Hakko Bio Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Placebo supplement Dietary Supplement: Citicoline supplement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo supplement
Cellulose
Other Name: Placebo
Experimental: Cognizin Dietary Supplement: Citicoline supplement
Cognizin
Other Name: Cognizin


Outcome Measures
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Primary Outcome Measures :
  1. Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369925


Locations
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United States, Illinois
Biofortis Clinical Research, Inc.
Addison, Illinois, United States, 60101
Sponsors and Collaborators
Kyowa Hakko Bio Co., Ltd.
Biofortis Clinical Research, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyowa Hakko Bio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03369925    
Other Study ID Numbers: BIO-1707
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytidine Diphosphate Choline
Nootropic Agents