The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive function at varying dosages in healthy younger adults with self-reported attention problems.
The main question it aims to answer is what Change from baseline to Day 56 between AP-Brain (1g, 3g, or 5g) and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score and complex attention.
Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.
Males and females 18-39 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
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
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
Clinical diagnosis and/or prescribed treatment for ADHD (See Section 7.3.1)
Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., autism spectrum 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
Parallel
AP-Brain (1g)
Dietary supplementParticipants 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 APBrain capsule and 4 placebo capsules.
AP-Brain (3g)
Dietary supplementParticipants 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 3 APBrain capsules and 2 placebo capsules
AP-Brain (5g)
Dietary supplementParticipants 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 5 APBrain capsules and 0 placebo capsules
Placebo
Dietary supplementParticipants 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 0 AP-Brain capsules and 5 placebo capsules.
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, 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 domain
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by complex attention via the CNS VS battery test
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, 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.
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.
Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in NCI Score assessed via CNS VS test battery.
Change from pre- to post-dose (t = 3h) at Days 56 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.
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in Complex attention via CNS VS test battery
Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: 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.
Incidence of pre-emergent and post-emergent adverse events (AE)
Incidence of pre-emergent and post-emergent adverse events (AE)
Clinically relevant changes in vital signs (blood pressure (BP) after supplementation
Clinically relevant changes in vital signs (blood pressure (BP) after supplementation
Clinically relevant changes in heart rate (HR)) after supplementation
Clinically relevant changes in heart rate (HR)) after supplementation
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Rousselot BVBA
Lead sponsor
KGK Science Inc.
Collaborator
