A Study to Investigate the Safety and Efficacy of NeuroQ on Cognitive Function in Health Adults with Self-Reported Memory Problems

NCT ID: NCT06672094

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2024-07-23

Brief Summary

The objective of this study is to investigate the safety and efficacy of NeuroQ on cognitive function in a North American population of healthy adults with self-reported memory problems compared to placebo. The difference in change in cognitive function as assessed by the CNS Vital Signs (CNS VS) Neurocognitive Index (NCI) score between NeuroQ and placebo will be measured from baseline at Day 60. Additionally, the safety and tolerability of NeuroQ, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs). Participants will take two capsules containing NeuroQ or placebo once a day for 60 days, have 4 in-person clinic visits, and keep a diary of their symptoms and number of missed doses.

Conditions

Healthy; Self-reported Memory Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NeuroQ

Participants will be instructed to take two (2) capsules of NeuroQ every morning with or without food starting on Day 1. Clinic staff will instruct participants to save all unused and open packages and return them to KGK Science Inc. for a determination of compliance. If a dose is missed participants are instructed to re-start their regular dosing the next day and document the missed dose in their study diary. Participants will be advised not to exceed two capsules daily.

Group Type: EXPERIMENTAL

NeuroQ

Intervention Type: DIETARY_SUPPLEMENT

Two (2) capsules of NeuroQ taken once a day for 60 days.

Placebo

Participants will be instructed to take two (2) capsules of placebo every morning with or without food starting on Day 1. Clinic staff will instruct participants to save all unused and open packages and return them to KGK Science Inc. for a determination of compliance. If a dose is missed participants are instructed to re-start their regular dosing the next day and document the missed dose in their study diary. Participants will be advised not to exceed two capsules daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Two (2) capsules of placebo taken once a day for 60 days.

Interventions

NeuroQ

Two (2) capsules of NeuroQ taken once a day for 60 days.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Two (2) capsules of placebo taken once a day for 60 days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males and females 40-79 years of age, inclusive

2. 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

3. Individuals with self-reported memory problems as assessed by a combined score of ≥6 on Everyday Memory Questionnaire questions 1, 2 and 18 at screening

4. Absence of dementia or other significant cognitive impairment as assessed by Mini Mental State Examination-2 Standard Version (MMSE-2) score ≥24 at screening

5. Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks), NSAIDs, and alcohol consumption for 24 hours prior to in-clinic visits

6. Agrees to avoid first generation anti-allergy medication for 48 hours prior to in-clinic visits

7. Agrees to avoid moderate-vigorous exercise 12 hours prior to in-clinic visits

8. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study

9. Willing and able to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits

10. Provided voluntary, written, informed consent to participate in the study

11. Healthy as determined by medical history, laboratory results, and vital signs, as assessed by the QI

Exclusion Criteria

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

2. Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients

3. Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., 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

4. Self-reported color blindness/weakness as assessed by the QI

5. Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI

6. Individuals with >2 chronic diseases and/or acute disease as assessed by the QI

7. Individuals with amyloidosis and/or cystinuria

8. Current employment that calls for overnight shiftwork as assessed by the QI

9. Travel across two or more time zones two weeks prior to any study visit

10. Unstable metabolic disease or chronic diseases as assessed by the QI

11. Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, as assessed by the QI

12. 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)

13. Type I diabetes

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. Individuals with an autoimmune disease or are immune compromised as assessed by the QI

21. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI

22. Self-reported confirmation of blood/bleeding disorders as assessed by QI

23. Use of medical cannabinoid products

24. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period

25. 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

26. Alcohol intake average of >2 standard drinks per day as assessed by the QI

27. Alcohol or drug abuse within the last 12 months

28. Current use of prescribed and/or over-the-counter (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)

29. Clinically significant abnormal laboratory results at screening as assessed by the QI

30. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit

31. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI

32. Individuals who are cognitively impaired and/or unable to give informed consent

33. 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LifeSeasons Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

23LSCNF01

Identifier Type: -

Identifier Source: org_study_id