Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

Kirin Holdings

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo supplement; Dietary Supplement: Citicoline supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04967157

BIO-2104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 148 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intervention: Dietary Supplement: Placebo supplement

Treatment:

Dietary Supplement: Placebo supplement

Cognizin®

Experimental group

Description:

Intervention: Dietary Supplement: Citicoline supplement

Treatment:

Dietary Supplement: Citicoline supplement