A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Effects of Cognizin ® Citicoline on Cognitive Performance in Generally Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- To evaluate the effect of the Test Product (TP) on cognitive performance compared to a placebo after 12 weeks using the Psychomotor Vigilance Test (PVT)
研究概览
简要总结
Cognizin is a patented form of citicoline, a natural compound of the brain tissue.
It is believed that Cognizin can support brain function by boosting brain energy and protecting brain cells. Research suggests that Cognizin can improve different aspects of brain function and affects cognitive performance in healthy adults.
详细描述
This study is a prospective, randomized, placebo-controlled, double-blind trial designed to assess the effects of Cognizin on cognitive performance in healthy young adults.
Participants will be randomized in a 1:1 ratio to either the test product (TP) or placebo (PL). During the study, participants cognitive performance will be assessed using the Psychomotor Vigilance Test (PVT) at baseline and after 12 weeks.
Safety assessments will be conducted throughout the study.
Note: The Unique Protocol ID K05-24-01-T0060 was unintentionally combined with another Unique Protocol ID, Bio-2104. As a result, the first protocol record for K05-24-01-T0060 was released in September 2024, prior to participant recruitment and randomization. The study start date was November 2024.
This explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The placebo will match the TP in physical and visual appearance and packaging and each participant's study product assignments will be associated with a unique code to prevent premature unblinding. Planned unblinding will occur following database lock, definition of study populations, and a blinded statistical analysis Delegated unblinded site personnel will be responsible for study product accountability, reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposition records) throughout the course of the study. The investigator will have oversight in a blinded manner.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and females who are 18-35 years of age (inclusive) at screening.
- •Body mass index (BMI) between 18.0 to 34.9 kg/m2 (inclusive).
- •In good general health and are able to swallow capsules.
- •Participants agree to maintain their usual caffeine consumption habits.
- •Participants who have habitually eaten breakfast for at least 1 month before screening, and agree to eat breakfast daily, and take study product with this meal when applicable as instructed, for the duration of the study.
- •MMSE score >24 at screening.
- •Naïve to oral cannabis or hemp, or light user of oral cannabis or hemp products (not more than 2 times per month on average).
- •Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study- related procedures.
排除标准
- •Females who are lactating, pregnant or planning to become pregnant during the study.
- •Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- •Are receiving treatments, or have been hospitalized in the last 12 months, for psychiatric disorders and/or brain-related medical conditions.
- •Participants who have habitually used any nicotine-containing products in the past 6 months before screening.
- •Individuals with any pre-existing neuromuscular disorder, physical disability, or injury.
- •Have inadequate sleep schedule defined as an average of less than 6 hours per night.
- •Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease
- •Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised.
- •Currently have cancer or have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurred at least 5 years before the screening visit.
- •Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing and digestion.
- •Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product.
- •Reports a clinically significant illness during the 28 days before the first dose of study product.
- •Major surgery in 3 months prior to screening or planned major surgery during the study.
- •Currently consumes more than two (2) standard alcoholic beverages per day on average for the two weeks prior to screening.
- •Have a history of alcohol or substance abuse in the 12 months prior to screening
- •Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer.
- •Any other medical condition/situation or use of medications/ supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
结局指标
主要结局
To evaluate the effect of the Test Product (TP) on cognitive performance compared to a placebo after 12 weeks using the Psychomotor Vigilance Test (PVT)
时间窗: 12 weeks
次要结局
- To evaluate the effect of the TP on attention control to a placebo after 12 weeks using the Stroop squared task, Flanker squared task and Simon squared task.(12 weeks)
- To evaluate the effect of the TP on motor speed to a placebo after 12 weeks by using the Finger-Tapping test.(12 weeks)