Cognitive Effects of Citicoline on Attention in Healthy Men and Women

Study Overview
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Brief Summary
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The objective of this trial is to determine the effects of citicoline on cognitive performance for attention in healthy Men and Women compared to a placebo.

Detailed Description
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This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women. Cognitive assessments will be performed to determine whether citicoline administration improves attention, compared to placebo administration.

Official Title
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A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Cognitive Effects of a Citicoline Supplement (Cognizin®) on Attention in Healthy Men and Women

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo supplement
* Dietary Supplement: Citicoline supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female, 35-75 years of age Scores ≥24 on the MMSE, ≤15 on the CESD-R, and scores below the population median (i.e., below 81.25, above 36.8) on the Gradual CPT Self-reported poor attention 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 Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator. Exclusion Criteria: color blindness Known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the breakfast meal provided major medical or neurological illness diagnosis of attention deficit hyperactive disorder (ADHD) 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intervention: Dietary Supplement: Placebo supplement | Dietary Supplement: Placebo supplement<br>* Cellulose<br>* Other names: Placebo;|
| Experimental: Cognizin®<br>Intervention: Dietary Supplement: Citicoline supplement | Dietary Supplement: Citicoline supplement<br>* Cognizin®<br>* Other names: Cognizin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment |  | 12 weeks |