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| Name | Class |
|---|---|
| Biofortis Clinical Research, Inc. | INDUSTRY |
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The objective of this trial is to determine the effects of citicoline on cognitive performance for attention in healrhy Men and Women compared to a placebo.
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.
**Note: This note is to inform you that the Unique Protocol ID BIO-2104 was unintentionally combined with another Unique Protocol ID, K5-24-01-T0060, resulting in history records that should not be considered as part of the BIO-2104's timeline.
This explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intervention: Dietary Supplement: Placebo supplement |
|
| Cognizin® | Experimental | Intervention: Dietary Supplement: Citicoline supplement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo supplement | Dietary Supplement | Cellulose |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Kelley, MD | Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research, Inc. | Addison | Illinois | 60101 | United States |
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| Citicoline supplement | Dietary Supplement | Cognizin ® |
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