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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Citicoline supplement; Dietary Supplement: Placebo supplement

• Registration Number: NCT03369925
• Lead Sponsor: Kyowa Hakko Bio Co., Ltd.

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 Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-12
• Study Start: 2018-01-02
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognizin	Citicoline supplement	-
Placebo	Placebo supplement	-

Primary Outcome Measures

Name	Time	Method
Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment	12 weeks

Trial Locations

Locations (1)

Biofortis Clinical Research, Inc.; 🇺🇸 Addison, Illinois, United States