HealthyPhase 2NCT06672094
A Study to Investigate the Safety and Efficacy of NeuroQ on Cognitive Function in Health Adults with Self-Reported Memory Problems
A Phase 2 study testing NeuroQ in people with Healthy and Self-reported Memory Problems, run by LifeSeasons Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Self-reported Memory Problems
- What is being tested?
- NeuroQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2024to 23 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- 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
- 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 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)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of NeuroQ on Cognitive Function in Healthy Adults with Self-reported Memory Problems.
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
- Being tested
- NeuroQ, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroQDietary supplement
Two (2) capsules of NeuroQ taken once a day for 60 days.
PlaceboOther
Two (2) capsules of placebo taken once a day for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline (day 0) and 60 days
Secondary outcomes (7)
The difference in change in cognitive function between NeuroQ and placebo in NCI score
The difference in change in cognitive function as assessed by the CNS VS between NeuroQ and placebo in NCI score from baseline at Day 7
Measured: baseline (day 0) and 7 days
The difference in change in cognitive function between NeuroQ and placebo in individual domain scores
The difference in change in cognitive function as assessed by the CNS VS between NeuroQ and placebo in individual domain scores from baseline at Day 7
Measured: baseline (day 0) and 7 days
The difference in change in cognitive function between NeuroQ and placebo in individual domain scores
The difference in change in cognitive function as assessed by the CNS VS between NeuroQ and placebo in individual domain scores from baseline at Day 60
Measured: baseline (day 0) and 60 days
The difference in change in brain-derived neurotrophic factor (BDNF) between NeuroQ and placebo
The difference in change in brain-derived neurotrophic factor (BDNF) between NeuroQ and placebo from baseline at Day 7
Measured: baseline (day 0) and 7 days
The difference in change in BDNF between NeuroQ and placebo
The difference in change in BDNF between NeuroQ and placebo from baseline at Day 60
Measured: baseline (day 0) and 60 days
The difference in change in C-reactive protein (CRP) between NeuroQ and placebo
The difference in change in C-reactive protein (CRP) between NeuroQ and placebo from baseline at Day 60
Measured: baseline (day 0) and 60 days
The difference in change in memory between NeuroQ and placebo
The difference in change in memory as assessed by the Everyday Memory Questionnaire questions 1, 2, and 18 between NeuroQ and placebo from baseline at Day 60
Measured: baseline (day 0) and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start25 Mar 2024
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeSeasons Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672094
- Sponsor's protocol ID
- 23LSCNF01
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of NeuroQ on Cognitive Function in Healthy Adults with Self-reported Memory Problems.
- ClinicalTrials.gov ID
- NCT06672094
- Acronym / sponsor ID
- 23LSCNF01
- Conditions
- Healthy, Self-reported Memory Problems
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LifeSeasons Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroQ | Experimental | Dietary Supplement: NeuroQParticipants 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroQTwo (2) capsules of NeuroQ taken once a day for 60 days. | Dietary supplement | NeuroQ |
| PlaceboTwo (2) capsules of placebo taken once a day for 60 days. | Other | Placebo |
Primary outcome
The difference in change in cognitive function between NeuroQ and placebo.
Time frame: baseline (day 0) and 60 days
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
7 secondary outcomes
The difference in change in cognitive function between NeuroQ and placebo in NCI score
Time frame: baseline (day 0) and 7 days
The difference in change in cognitive function between NeuroQ and placebo in individual domain scores
Time frame: baseline (day 0) and 7 days
The difference in change in cognitive function between NeuroQ and placebo in individual domain scores
Time frame: baseline (day 0) and 60 days
The difference in change in brain-derived neurotrophic factor (BDNF) between NeuroQ and placebo
Time frame: baseline (day 0) and 7 days
The difference in change in BDNF between NeuroQ and placebo
Time frame: baseline (day 0) and 60 days
The difference in change in C-reactive protein (CRP) between NeuroQ and placebo
Time frame: baseline (day 0) and 60 days
The difference in change in memory between NeuroQ and placebo
Time frame: baseline (day 0) and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NeuroQ in people with Healthy and Self-reported Memory Problems, run by LifeSeasons Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in cognitive function between NeuroQ and placebo. (time frame: baseline (day 0) and 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.