Welcome!
We know you might have questions about our research study.
Welcome to the Memory & Cognition clinical study. This study is to assess the safety and efficacy of AP Brain of various dosages and its effect on cognition in healthy middle-aged adults
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
Memory & Cognition Study Introduction Video
2.Please Review the ICF Form here.
Please review the Informed Consent Form. You do not need to sign this copy but will be required to sign an electronic copy when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
The clinical trial will explore the safety and efficacy of the investigational product AP-Brain (1g, 3g, and 5g) on overall cognitive performance in healthy adults with self-reported memory problems.
What do the study products contain?
- If you are enrolled into the study, you will receive either the investigational product or the placebo at varying doses.
- The investigational product contains:
Medicinal Ingredient | Quantity (g/unit) |
Hydrolyzed bovine collagen | 1 |
Non-medicinal ingredients: Silicified Microcrystalline Cellulose, magnesium stearate, Hydroxypropyl cellulose, titanium dioxide
- The placebo contains: Silicified Microcrystalline Cellulose, magnesium stearate, Hydroxypropyl cellulose, titanium dioxide
What side effect might I experience during the study?
- It is possible that you could have problems or side effects from the study product that nobody knows about yet. There may be unknown risks with taking the study product.
- Potential side-effects of taking the study product may include:
- Gastrointestinal Symptoms like (Abdominal discomfort, Bloating, Changes in stool, Nausea and Vomiting)
- Headache
- Tiredness
- Insomnia (Trouble sleeping)
- Mild skin irritation
- Some risks associated with blood collection may include pain, bruising, and infection at the site. Alcohol swabs and proper blood collection procedures will be followed to minimize the risk of infection. Fainting during a blood draw can occur, though it is not common. Please advise the study staff if you normally faint with blood draw
How often and when do I need to take study product?
- On study visits 2 and 4, you will be instructed to take one dose (5 tablets) of the study product with a standardized meal during your in-clinic visit.
- Starting the day after Visit 2 and until the day before your last visit, you will take one dose (5 tablets) of the study product at home each morning with breakfast and a glass of water.
- You will save all unused and open study product packaging and return them to the clinic, for a determination of compliance.
- If a dose or portion of the dose is missed, take the missed dose as soon as you remember with a snack or at your next meal.
- Do not take more than one dose (5 tablets) daily.
How/when will I receive the product?
You will receive the study product for both clinic and at-home use during your visits at no cost to yourself.
How/ when can I find out if I got the investigational product or the placebo?
- This study is designed to be triple-blinded. Neither you, the study staff, nor the researchers analyzing the data will know which group you have been assigned to.
- If you are interested in learning if you received the product or placebo, we can let you know at a later date, when all participants have completed the study and statistical analysis of the data has been completed.
How long will the study last?
Once you receive your study product your participation will continue for approximately 56 days.
What does randomization mean?
Randomized means that you will be assigned by chance, like flipping a coin, to a study group. Based on your group, you may receive the investigational product, a placebo, or both (at different doses).
Do I have to come into the clinic for any assessments?
Yes, after the screening period, there are 3 clinic visits over a 56 day period
What are the assessments associated with the study visits?
- Blood Pressure and Heart Rate
- Height and Weight
- Blood Sample collection
- Memory Assessment (The Everyday Memory Questionnaire was developed as a subjective measure of memory failure in everyday life. A modified version of questions will be used as a screening tool at Visit 1 to identify individuals with self-reported memory problems)
- Mini Mental State Examination-2 Standard version (The MMSE-2 Standard Version is equivalent to the original MMSE and is widely used for measuring cognitive impairment. This 30-point questionnaire will assess seven areas of cognition to identify those with memory problems. The MMSE-2 will be administered at Visit 1 to screen potential volunteers for eligibility)
- CNS Vital Signs (The CNS VS test battery is a validated cognitive assessment tool comprised of seven neurocognitive tests including a verbal and visual memory test, a finger tap test, symbol digit coding, the Stroop Test, a shifting attention test, and the continuous performance test. The CNS VS generates scores for the Neurocognitive Index which includes Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility, and for all individual domains.)
- Product Perception Questionnaire (The PPQ will be used at the end of the study to assess the product tolerability, perception and likeability. The PPQ consists of eight questions in which responses will be reported on a 5-point scale from strongly agree to strongly disagree as well as an open-ended question for any further comments )
Who/how do I contact if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of $600 if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participating?
- After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard on your final visit.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Is my participation confidential?
- Yes! KGK Science research staff will keep all of your personal medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.
Your participation is completely voluntary.
Take your time, ask questions, and only join the study if you feel comfortable.
Thank you for your interest in our study! If anything is unclear or you need more information, don’t hesitate to reach out.