A Clinical Trial to Investigate the Safety and Efficacy o... | NCT07388043

Name	Class
KGK Science Inc.	INDUSTRY

Label	Type	Description	Intervention Names
AP-Brain (1g)	Experimental	AP-Brain (1g) contains 1 g of hydrolyzed collagen in a capsule	Dietary Supplement: AP-Brain (1g)
AP-Brain (3g)	Experimental	AP-Brain (3 g) contains 3 g of hydrolyzed collagen in a capsule	Dietary Supplement: AP-Brain (3g)
AP-Brain (5g)	Experimental	AP-Brain (5 g) contains 5 g of hydrolyzed collagen in a capsule	Dietary Supplement: AP-Brain (5g)
Placebo	Placebo Comparator	Placebo consists of Silicified Microcrystalline Cellulose, magnesium stearate, Hydroxypropyl cellulose, and titanium dioxide	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AP-Brain (1g)	Dietary Supplement	Participants will be instructed to take one dose (5 tablets) of the study product with a standardized meal during their in-clinic visit. This group will receive 1 AP-Brain capsule and 4 placebo capsules.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by the CNS VS Neurocognitive Index (NCI) score	Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by the CNS VS Neurocognitive Index (NCI) score and complex attention. 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.	Day 0 to 56
Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by complex attention via the CNS VS battery test	Change from baseline to Day 56 between AP-Brain and placebo in cognitive performance, as assessed by complex attention. 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.	Day 0 to 56

Secondary Outcomes

Measure	Description	Time Frame
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in NCI Score as assessed by the CNS VS Neurocognitive Index (NCI) score.	Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: NCI Score. 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.

Other Outcomes

Measure	Description	Time Frame
Incidence of pre-emergent and post-emergent adverse events (AE)	Incidence of pre-emergent and post-emergent adverse events (AE)	Day 0 to 56
Clinically relevant changes in vital signs (blood pressure (BP) after supplementation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females 40-79 years of age, inclusive
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

Or,

Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active
Individuals with self-reported memory problems as assessed by a combined score of ≥6 from the memory assessment questions provided at screening
Absence of dementia or other significant cognitive impairment as assessed by MMSE-2 score of ≥24 at screening
Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks), NSAIDs, and alcohol consumption for 24 hours prior to post-screening clinic visits
Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits
Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits
Agrees to avoid travel across two or more time zones two weeks prior to any study visit
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Willing and able to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history, laboratory results, and vital signs, as assessed by the QI

Exclusion Criteria:

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., attention-deficit/hyperactivity disorder, Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
Self-reported color blindness/weakness as assessed by the QI
Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
Current employment that calls for overnight shiftwork as assessed by the QI
Unstable metabolic disease or chronic diseases as assessed by the QI
Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, as assessed by the QI
Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3.1)
Type I diabetes
Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an HbA1c of <8.0% may be included after assessment by the QI on a case-by-case basis
Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
History of or current diagnosis with kidney, gallbladder (e.g., gallstones, bile duct obstruction), and/or liver diseases (e.g., reduced bile salts, SIBO) as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
Individuals with an autoimmune disease or are immune compromised as assessed by the QI
Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
Self-reported confirmation of blood/bleeding disorders as assessed by QI
Use of medical cannabinoid products
Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
Alcohol intake average of >2 standard drinks per day as assessed by the QI
Alcohol or drug abuse within the last 12 months
Current use of prescribed and/or OTC medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
Current or previous use of cognitive training programs or therapies, as assessed by the QI
Clinically significant abnormal laboratory results at screening as assessed by the QI
Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
Individuals who are cognitively impaired and/or unable to give informed consent
Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant