Wellness Products for Cognitive Functioning

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

2594 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, and others listed in the exclusion criteria.

What evidence supports the effectiveness of the treatment Clarity Active Study Product 1.1 for improving cognitive functioning?

Research shows that nutraceuticals like Ginseng and Bacopa, which are often used for cognitive enhancement, have significant positive effects on memory and reaction time, similar to pharmaceutical drugs. This suggests that treatments containing similar components might also improve cognitive functioning. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The safety of dietary supplements for cognitive enhancement is uncertain, as many products have been found to contain unapproved or misbranded ingredients, which could pose health risks. It's important to be cautious and informed when considering these supplements, as they are often not thoroughly tested for safety. ^{4 6 7 8 9}

How is the treatment Clarity Active Study Product 1.1 different from other treatments for cognitive functioning?

Clarity Active Study Product 1.1 is unique because it is part of a clinical trial that includes a placebo control, which helps determine its specific effects on cognitive functioning compared to no treatment. Unlike standard pharmaceutical drugs, it may involve natural ingredients similar to those in other nutraceuticals like SuperUlam, which have shown improvements in cognitive flexibility and working memory. ^{4 10 11 12 13}

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

Adults over 21 in the U.S. who want to improve concentration or cognitive function and believe they can see at least a 20% improvement in these areas. Not for those with certain heart, liver, kidney diseases, pregnant or breastfeeding individuals, heavy drinkers, or those currently using similar products.

Inclusion Criteria

Resides in the United States

Has the opportunity for at least 20% improvement in their primary health outcome

I am 21 years or older and understand my participation may involve sex-specific aspects.

Exclusion Criteria

I have heart, liver, or kidney issues that make certain treatments unsafe for me.

Lack of reliable daily access to the internet

Unable to read and understand English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for cognitive function assessment

6 weeks

All assessments are electronic, no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Clarity Active Study Product 1.1
• Placebo Control Form 1

Trial Overview The study is testing health and wellness products on cognitive functioning by comparing an active product (Clarity Active Study Product 1.1) against a placebo. Participants won't know which one they're taking until the end of this randomized and double-blind trial.

Participant Groups

Group I: Active product 6.1.2 Experimental Treatment 1 Intervention

Clarity Product 6.1.2

Group II: Active Product 6.1.1 Experimental Treatment 1 Intervention

Clarity Product 6.1.1 - active product 1

Group III: Active Product 6.1 Experimental Treatment 1 Intervention

Clarity Product Form 6 - active product 1

Group IV: Active Product 5.2 Experimental Treatment 1 Intervention

Clarity Product Form 5 - active product 2

Group V: Active Product 5.1 Experimental Treatment 1 Intervention

Clarity Product Form 5 - active product 1

Group VI: Active Product 4.1 Experimental Treatment 1 Intervention

Clarity Product Form 4 - active product 1

Group VII: Active Product 3.2 Experimental Treatment 1 Intervention

Clarity Product Form 3 - active product 2

Group VIII: Active Product 3.1 Experimental Treatment 1 Intervention

Clarity Product Form 3 - active product 1

Group IX: Active Product 2.1 Experimental Treatment 1 Intervention

Clarity Product Form 2 - active product 1

Group X: Active Product 1.1 Experimental Treatment 1 Intervention

Clarity Product Form 1 - active product 1

Group XI: Placebo Control 3 Placebo Group 1 Intervention

Clarity Product Form 3 - control

Group XII: Placebo Control 6 Placebo Group 1 Intervention

Clarity Product Form 6 - control

Group XIII: Placebo Control 5 Placebo Group 1 Intervention

Clarity Product Form 5 - control

Group XIV: Placebo Control 2 Placebo Group 1 Intervention

Clarity Product Form 2 - control

Group XV: Placebo Control 4 Placebo Group 1 Intervention

Clarity Product Form 4 - control

Group XVI: Placebo Control 1 Placebo Group 1 Intervention

Clarity Product Form 1 - control

Group XVII: Placebo Control 6.1.0 Placebo Group 1 Intervention

Clarity Product 6.1.0 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Findings from Research

Practice effects (PEs) can significantly influence cognitive outcome assessments in Alzheimer's disease trials, as shown by the comparison of two trial designs using data from the Alzheimer's Disease Cooperative Study, which highlighted that a 15-month trial with a placebo run-in produced a more accurate measure of cognitive decline than a standard 19-month trial.

The study found that to detect a 50% slowing of cognitive decline, a future trial would need 3.4 times more participants without a run-in period, emphasizing the importance of accounting for PEs in trial design to avoid unnecessarily large sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential implications of practice effects in Alzheimer's disease prevention trials. Jacobs, DM., Ard, MC., Salmon, DP., et al.[2022]

A study involving 78 healthy volunteers over 21 days found that open-label placebo (OLP) treatment did not improve cognitive performance compared to baseline, as measured by both subjective and objective assessments.

The results suggest that while OLP treatment has shown benefits in other medical conditions, it may not be an effective alternative to pharmacological cognitive enhancers for boosting cognitive abilities in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label placebo treatment does not enhance cognitive abilities in healthy volunteers. Hartmann, H., Forkmann, K., Schmidt, K., et al.[2023]

In a study of 162 patients with age-associated memory impairment, a combination of piracetam (4.8 g) and cognitive therapy showed the most significant improvement in memory, particularly in those with the lowest baseline performance.

The optimal results were achieved when cognitive training sessions started after 6 weeks of piracetam treatment, indicating a potential timing effect in the intervention's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment. Israel, L., Melac, M., Milinkevitch, D., et al.[2019]

Modafinil, a pharmaceutical cognition enhancer, showed a significant effect size of 0.77 for improving visuospatial memory accuracy, indicating its efficacy in enhancing cognitive function.

Nutraceuticals like Ginseng and Bacopa demonstrated even higher effect sizes of 0.86 and 0.95, respectively, for cognitive tasks, suggesting that these natural supplements can enhance cognition comparably to pharmaceuticals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive effects of two nutraceuticals Ginseng and Bacopa benchmarked against modafinil: a review and comparison of effect sizes. Neale, C., Camfield, D., Reay, J., et al.[2021]

Cognition enhancers require long-term studies to demonstrate their therapeutic efficacy, as benefits are not typically observable in short-duration trials; thus, early results should not be misinterpreted as evidence of effectiveness.

To properly assess new cognition enhancers, larger sample sizes and precise outcome measures are essential, along with the development of normative and longitudinal data to guide study design and ensure adequate statistical power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early human trials in the assessment of cognition activators. Gamzu, ER., Birkhimer, LJ., Hoover, T., et al.[2005]

A study of 10 over-the-counter dietary supplements marketed for memory enhancement found that they contained unapproved drugs like omberacetam and aniracetam, with some products exposing consumers to pharmaceutical-level dosages.

Many of these supplements had inaccurate labeling, with 75% of declared drug quantities being incorrect, raising concerns about the safety and health effects of consuming untested combinations of unapproved drugs without medical supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five Unapproved Drugs Found in Cognitive Enhancement Supplements. Cohen, PA., Avula, B., Wang, YH., et al.[2022]

A review of 12 dietary supplements marketed for brain health revealed that 67% had ingredients listed on their labels that were not detected in the actual product, indicating potential misbranding.

Additionally, 83% of the products contained compounds that were not reported on the labels, and many scientific claims made by these products lacked scientific support, highlighting the need for consumer education and regulatory improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. Crawford, C., Boyd, C., Avula, B., et al.[2021]

Many dietary supplements marketed for brain health and cognitive enhancement, particularly those targeting Special Operations Forces, often contain misbranded labels and prohibited ingredients, raising safety concerns.

The Operation Supplement Safety scorecard algorithm is a useful tool for quickly assessing the safety of these supplements, helping to protect users from potentially harmful products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be in the Know: Dietary Supplements for Cognitive Performance. Crawford, C., Deuster, PA.[2022]

Pharmacological cognitive enhancement (CE) involves the use of various psychoactive substances, including over-the-counter drugs like caffeine, prescription medications for ADHD, and illicit drugs, but evidence shows these substances have limited cognitive benefits and pose significant safety risks.

Prevalence rates of CE drug use among healthy individuals vary widely, from less than 1% to over 20%, influenced by factors such as the population surveyed and the definitions of CE, highlighting the need for better data to inform healthcare policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substances used and prevalence rates of pharmacological cognitive enhancement among healthy subjects. Franke, AG., Bagusat, C., Rust, S., et al.[2014]

In a study involving 20 healthy adults aged 35-65, SuperUlam supplementation led to significant improvements in cognitive functions such as executive functioning, cognitive flexibility, reaction time, and working memory compared to placebo.

Participants taking SuperUlam also reported a significant reduction in feelings of tension, depression, and anger, indicating potential mood benefits, while no adverse events were reported, suggesting it is safe for consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. Udani, JK.[2021]

In a randomized, double-blind, placebo-controlled trial involving 63 healthy adults aged 18 to 35, Alpha BRAIN® significantly improved delayed verbal recall and executive functioning compared to a placebo over a 6-week period.

The study suggests that Alpha BRAIN® can enhance recent verbal memory in healthy individuals, but further research is needed to confirm these findings as this is the first randomized controlled trial of the supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally. Solomon, TM., Leech, J., deBros, GB., et al.[2016]

In a double-blind, placebo-controlled trial with 105 cognitively intact adults aged 65-85, the nutraceutical NT-020 showed significant improvements in processing speed over 2 months compared to a placebo group.

NT-020 was well tolerated by participants, with no significant differences in adverse events between the NT-020 and placebo groups, indicating it is a safe option for enhancing cognitive health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutraceutical intervention improves older adults' cognitive functioning. Small, BJ., Rawson, KS., Martin, C., et al.[2021]

Older adults with poorer cognitive function are more likely to use non-prescribed therapies, such as prayer and ignoring symptoms, when experiencing acute symptoms.

There is a significant association between lower cognitive function and increased reliance on home remedies for managing chronic conditions, suggesting cognitive ability influences treatment choices in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between cognitive function and non-prescribed therapy use in older adults. Nguyen, HT., Grzywacz, JG., Quandt, SA., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Potential implications of practice effects in Alzheimer's disease prevention trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Open-label placebo treatment does not enhance cognitive abilities in healthy volunteers. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive effects of two nutraceuticals Ginseng and Bacopa benchmarked against modafinil: a review and comparison of effect sizes. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Early human trials in the assessment of cognition activators. [2005]

6. United States pubmed.ncbi.nlm.nih.gov

Five Unapproved Drugs Found in Cognitive Enhancement Supplements. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Be in the Know: Dietary Supplements for Cognitive Performance. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Substances used and prevalence rates of pharmacological cognitive enhancement among healthy subjects. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Nutraceutical intervention improves older adults' cognitive functioning. [2021]

13. England pubmed.ncbi.nlm.nih.gov

The relationship between cognitive function and non-prescribed therapy use in older adults. [2021]