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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroQ | Dietary Supplement | Two (2) capsules of NeuroQ taken once a day for 60 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline (day 0) and 7 days |
| The difference in change in cognitive function between NeuroQ and placebo in individual domain scores |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pre-emergent and post-emergent adverse events (AE) | 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 |
Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B 3L1 | Canada |
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| Placebo |
| Other |
Two (2) capsules of placebo taken once a day for 60 days. |
|
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 |
| 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 | 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 | 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 | 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 | 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 | 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 | Clinically relevant changes in aspartate aminotransferase (AST) after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in alanine aminotransferase (ALT) after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in alkaline phosphatase (ALP) after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in total bilirubin after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in creatinine after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in sodium after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in potassium after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in chloride after supplementation | baseline (day 0) and 60 days |
| Clinically relevant changes in clinical chemistry | Clinically relevant changes in estimated glomerular filtration rate (eGFR) after supplementation | baseline (day 0) and 60 days |