Cognitive Support
Clinical trials for memory-boosting and brain-supporting natural products
Memory naturally declines with age, women frequently suffer from "pregnancy brain" or "mom brain", and with the recent pandemic, even more Americans are suffering from brain fog. Globally, the brain health market is exploding, confirming that consumers want cognitive-enhancing products.
You've got a product that can help consumers solve this problem. But today's consumers want more than brand assurance; they want evidence. A clinical trial provides the evidence your brand needs to build consumer trust and help the world think, work, and live better.
Endpoints for Brain Health Studies
Brain fog. Mental fatigue. Foggy headed. We have dozens of terms to describe sluggish cognitive function because it impacts such a wide range of people in many different ways. But when it comes to trials on cognition, many research firms resort to tools meant for diagnosing cognitive disorders such as Alzheimer's and dementia rather than for measuring healthy brains. But your product isn't a pharmaceutical for people with diagnosed disorders; it's a natural product that supports brain health in everyone who suffers from everyday issues such as brain fog or absentmindedness. Your trial endpoints need to match your product's effects.
So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical boosts cognitive well-being among people who don't have a cognitive disorder? Nutraceuticals Research Institute helps you meet this challenge with our proprietary Cognitive Wellbeing Scale (FHCWS).
The FHCWS is the first tool of its kind developed exclusively for the natural products industry to measure improvements in healthy brain function. This comprehensive measurement focuses on a holistic approach and includes multiple facets of cognition ranging from memory to quality of life. Unlike existing dementia-focused scales, this tool concentrates on the wide range of areas in which brain health can be improved and focuses on real world outcomes that matter to your consumers.
A natural products cognition trial at Nutraceuticals Research Institute will typically focus on 5-6 key endpoints, though your trial's endpoints will be hand-selected by our research team to match your brain boosting product's greatest effects. Our most commonly used endpoints include:
Memory
Capture changes to recall, including long-term recall, of important events, dates, and more.
Acuity
Document improved decision-making, judgement, and problem-solving.
Function
Document improvements to executive functioning through activities such as planning and organizing.
Focus
Capture improvements to focus, attention, and concentration levels.
Working Memory
Prove your product's ability to increase ability to hold information in the brain during tasks.
Quality of Life
Demonstrate improvements to perceived wellbeing, including physical and emotional traits.
Cognition Clinical Trials
Brain-enhancing products need to demonstrate beneficial effects in otherwise healthy populations–individuals. This can be challenging but highly rewarding.
Working with Nutraceuticals Research Institute for a high quality clinical trial with a cognition-boosting outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:
- restores mental alertness
- improves memory
- helps with mild memory problems associated with age
- boosts healthy mental function
- diminishes the cognitive effects of stress
Cognitive health can be selected as a primary, secondary, or tertiary endpoint for a nutraceutical study. It serves as a fantastic addition to studies targeting stress, gut health, or sleep; it can also be enhanced by adding outcomes such as mood.
Questions About Brain-Boosting Trials
-
Is your cognition scale validated?
We love talking about our proprietary suite of psychometric measurement instruments!
These tools were developed to far exceed recommendations in the FDA's guidance on the use of Patient Reported Outcome Measures (PROMs) for the substantiation of labeling claims. The scale contains a combination of subjective and objective data which are aggregated to produce total scores on each of the cognition-related subdomains.
Each of our measures are validated and norm-referenced in a population of healthy adult females. Our development priorities include elimination of floor or ceiling effects in this priority population as well as ensuring that each domain has highly precise sensitivity to change.
Our cognition scale was developed and pilot tested with focus groups and qualitative research to ensure face and content validity. It was then tested for psychometric properties using confirmatory factor analysis and item response theory. Internal reliability was determined via Cronbach's alpha.
Our brain health subscales have Cronbach's alpha scores ranging from .82 to .90, which is an ideal range for both exceeding minimum standards for internal reliability while avoiding redundancy and participant burden.
Confirmatory factor analysis confirmed that each subscale measures a single latent factor, with each subscale contributing to the broad latent factor of cognition Factor loadings were all below 0.5, SRMRs were below 0.8, and coefficient of determinations were above 0.8.
In item response theory testing using graded response modeling, each item in the final version of the scale was found to be highly discriminating with IRT discrimination (trait) parameters all above 1.5 and over 50% of item trait parameters above 2.0. Difficulty parameters and test information curves identified that the test is most reliable within +/- 1.5 standard deviations of the mean.
Practically speaking, this means that the test is calibrated to identify brain health among an average American female adult population and is capable of identifying changes that go both above and below the norm. This ensures that our measures capture the totality of your product's effects on each specific type of cognition.
-
How long does a brain boosting trial take?
We create each and every trial around your product's key benefits. The intervention period is going to be the driving factor in the trial's total duration.
As a general rule, plan on 6-8 weeks from contract execution to the first participant's start date. This time is for protocol development and obtention of ethical authorizations/registrations. This is the most important timeframe of the entire study as it lays the groundwork for a trial that meets our high standards of quality and is capable of staying on the target timeline.
Following the first participant's start date, we typically recommend adding 2 months to the total intervention period for us to hand-select each participant in your study among our nationwide community of participants. This means that a 1-week intervention would require approximately 9 weeks for this phase, whereas a 3-month intervention would require approximately 5 months.
After all data are collected, our team audits each dataset to ensure accuracy. We then clean the data, construct the outcome variables from the data collected, and begin statistical analysis. This phase takes 4-6 weeks on average. More complex studies with multiple outcomes can take several months.
Once outcomes are confirmed, we immediately provide you a quick review of the findings. Our team then spends another 2-4 weeks creating a long-form technical report that goes into precise details of the entire study, a submission-ready scientific manuscript for publication of the findings, and a full color lookbook which contains the technical report contents as well as attention catching graphs and charts. This ensures that everyone on your team, from legal to scientific to marketing, has access to the findings in the form that best meets their needs.
-
How does your approach of custom protocol creation affect the budget?
We design custom trial strategies around the needs of your brain support products Our expert approach to clinical trial design focuses on the quality of your trial and FDA/FTC natural product-specific guidelines for dietary supplements. We prioritize ethics compliance, data protection, and quality control over wasteful and irrelevant systems borrowed from other industries.
Through this approach, we're able to reduce inefficiencies in the research process and eliminate needless overhead costs that are not relevant to the standards for health-enhancing products.
Not only does this approach substantially reduce the cost of a clinical trial for your cognition enhancing product, it also improves the quality of the trial. It's a win-win.
So what does this actually look like for your trial? At Franklin, we prioritize transparent pricing. Each and every trial is a bespoke design based on your energizing product's unique needs, with your budget and goals in mind. With our extensive expertise in natural products and clinical research, we're often able to come up with creative solutions to work with any trial budget.
The typical randomized, double-blinded placebo-controlled clinical trial for a cognition product varies based on a number of factors. On the lower end, a trial may run anywhere from $35,000-$65,000 for a week-long aromatherapy based study with 60 people. On the upper end, a 3-4 month intervention with larger groups and more complex analyses can run into the low-$200,000 range. Our scientists will work with you to develop a trial that captures the real world effects of your product while staying within the confines of your budget.
Endpoints for Brain Health Studies
Brain fog. Mental fatigue. Foggy headed. We have dozens of terms to describe sluggish cognitive function because it impacts such a wide range of people in many different ways. But when it comes to trials on cognition, many research firms resort to tools meant for diagnosing cognitive disorders such as Alzheimer's and dementia rather than for measuring healthy brains. But your product isn't a pharmaceutical for people with diagnosed disorders; it's a natural product that supports brain health in everyone who suffers from everyday issues such as brain fog or absentmindedness. Your trial endpoints need to match your product's effects.
So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical boosts cognitive well-being among people who don't have a cognitive disorder? Nutraceuticals Research Institute helps you meet this challenge with our proprietary Cognitive Wellbeing Scale (FHCWS).
The FHCWS is the first tool of its kind developed exclusively for the natural products industry to measure improvements in healthy brain function. This comprehensive measurement focuses on a holistic approach and includes multiple facets of cognition ranging from memory to quality of life. Unlike existing dementia-focused scales, this tool concentrates on the wide range of areas in which brain health can be improved and focuses on real world outcomes that matter to your consumers.
A natural products cognition trial at Nutraceuticals Research Institute will typically focus on 5-6 key endpoints, though your trial's endpoints will be hand-selected by our research team to match your brain-boosting product's greatest effects. Our most commonly used endpoints include: