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

NCT06672094 | Completed Phase 2

• 1 other identifier: 23LSCNF01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The difference in change in cognitive function between NeuroQ and 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 from baseline at Day 60

  baseline (day 0) and 60 days

Secondary Outcomes (7)

• The difference in change in cognitive function between NeuroQ and placebo in NCI score

  baseline (day 0) and 7 days

• The difference in change in cognitive function between NeuroQ and placebo in individual domain scores

  baseline (day 0) and 7 days

• The difference in change in cognitive function between NeuroQ and placebo in individual domain scores

  baseline (day 0) and 60 days

• The difference in change in brain-derived neurotrophic factor (BDNF) between NeuroQ and placebo

  baseline (day 0) and 7 days

• The difference in change in BDNF between NeuroQ and placebo

  baseline (day 0) and 60 days

Other Outcomes (11)

• Incidence of pre-emergent and post-emergent adverse events (AE)

  baseline (day 0) and 60 days

• Clinically relevant changes in complete blood count after supplementation

  baseline (day 0) and 60 days

• Clinically relevant changes in clinical chemistry

  baseline (day 0) and 60 days

Study Arms (2)

NeuroQ

EXPERIMENTAL

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.

Dietary Supplement: NeuroQ

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

NeuroQ DIETARY_SUPPLEMENT

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

NeuroQ

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 on Everyday Memory Questionnaire questions 1, 2 and 18 at screening
• Absence of dementia or other significant cognitive impairment as assessed by Mini Mental State Examination-2 Standard Version (MMSE-2) score ≥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 in-clinic visits
• Agrees to avoid first generation anti-allergy medication for 48 hours prior to in-clinic visits
• Agrees to avoid moderate-vigorous exercise 12 hours prior to in-clinic visits
• Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study

You may not qualify if:

• 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., 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
• Individuals with \>2 chronic diseases and/or acute disease as assessed by the QI
• Individuals with amyloidosis and/or cystinuria
• Current employment that calls for overnight shiftwork as assessed by the QI
• Travel across two or more time zones two weeks prior to any study visit
• 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

Sponsors & Collaborators

• LifeSeasons Inc.: lead

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 4, 2024
• Study Start: March 25, 2024
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)