A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Varying Dosages in Healthy Younger Adults With Self-reported Attention Problems

Official title

A Randomized, Triple-blind, Placebo-controlled, Parallel, Proof-of-concept Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Varying Dosages in Healthy Younger Adults With Self-reported Attention Problems

Overview

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.

Interventions

• Dietary supplement AP-Brain (1g)
  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 APBrain capsule and 4 placebo capsules.
• Dietary supplement AP-Brain (3g)
  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 3 APBrain capsules and 2 placebo capsules
• Dietary supplement AP-Brain (5g)
  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 5 APBrain capsules and 0 placebo capsules
• Dietary supplement Placebo
  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 0 AP-Brain capsules and 5 placebo capsules.

Primary outcome measures

• Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score [Time frame: Day 0 to 56]

Secondary outcome measures (12)

• 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 [Time frame: Day 0 to 56]
• 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. [Time frame: Day 0 and 1]
• 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. [Time frame: Day 0 and 56]
• Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in Complex attention via CNS VS test battery [Time frame: Day 0 and 1]
• Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in Complex attention via CNS VS test battery [Time frame: Day 0 and 56]]
• Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in Verbal, visual, composite, and working memory assessed via CNS VS test battery. [Time frame: Day 0 and 1]
• Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in Verbal, visual, composite, and working memory assessed via CNS VS test battery. [Time frame: Day 0 and 56]]
• Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Processing, motor, and psychomotor speed assessed via CNS VS test battery. [Time frame: Day 0 and 1]
• Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Processing, motor, and psychomotor speed assessed via CNS VS test battery. [Time frame: Day 0 and 56]
• Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Reaction time assessed via CNS VS test battery. [Time frame: Day 0 and 1]]
• Change from pre- to post-dose (t = 3h) at Days 56 between AP-Brain and placebo in the following CNS VS measures: Reaction time assessed via CNS VS test battery. [Time frame: Day 0 and 56]
• Change from pre- to post-dose (t = 3h) at Days 1 between AP-Brain and placebo in the following CNS VS measures: Simple and sustained attention assessed via CNS VS test battery. [Time frame: Day 0 and 1]

Eligibility criteria

Inclusion criteria

• 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

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 focus or attention problems, as determined by QI assessment of the Adult Attention Deficit Hyperactivity Disorder Self-Report Scale (Part A) (ASRS; version 1.1) (20)
• 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
• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Canada · 2 centers

• KGK Science Inc. — London
• KGK Science Inc. — London

Identifiers

NCT: NCT07388576 · 25RBCCT03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗