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

• ClinicalTrials.gov Identifier: NCT03369925
• Recruitment Status: Completed
• First Posted: December 12, 2017
• Last Update Posted: February 27, 2019
• Sponsor: Kyowa Hakko Bio Co., Ltd.
• Collaborator: Biofortis Clinical Research, Inc.
• Information provided by (Responsible Party): Kyowa Hakko Bio Co., Ltd.

Tracking Information

• First Submitted Date: December 7, 2017
• First Posted Date: December 12, 2017
• Last Update Posted Date: February 27, 2019
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: December 3, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 7, 2017): Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment
• 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
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Dietary Supplement: Placebo supplement
  Cellulose
  Other Name: Placebo
• Dietary Supplement: Citicoline supplement
  Cognizin
  Other Name: Cognizin

Study Arms

• Placebo Comparator: Placebo
  Intervention: Dietary Supplement: Placebo supplement
• Experimental: Cognizin
  Intervention: Dietary Supplement: Citicoline supplement

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2017): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 3, 2018
• Actual Primary Completion Date: December 3, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03369925
• Other Study ID Numbers: BIO-1707
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kyowa Hakko Bio Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Kyowa Hakko Bio Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Biofortis Clinical Research, Inc.
• Investigators: Not Provided
• PRS Account: Kyowa Hakko Bio Co., Ltd.
• Verification Date: February 2019