Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health

Inclusion criteria

• Individuals 40-75 years old, inclusive
• Has self-reported concerns with reduced memory, focus and cognitive decline
• Cognitive Failures Questionnaire score of mild to moderate at screening
• Interested in understanding more about their cognitive health and have chosen have chosen to use the study product
• Willing to do a 4-week washout from any supplements for memory or cognitive function prior to randomization
• Willing to do a 4-week washout prior to randomization from supplements with mushroom compounds or consuming mushrooms known to impact NGF. This includes but may not be limited to: Reishi (ganoderma lucidum), cordyceps (cordyceps militaris or cordyceps sinensis), Lion's mane or Coral Tooth Fungus (hericium coralloides), turkey tail (trametes versicolor), Chage (inonotus obliquus), Maitake (grifola frondosa).
• If taking prescription medications for sleep (e.g. Benzodiazepines, zolpidem, zaleplon), or other class of medication for sleep, must be on a "stable dose" for at least 4 weeks prior to enrollment. "Stable dose" is defined as no changes in dosage or frequency of the specified medications for at least 4 weeks prior to enrollment and throughout the study period.
• If regularly consuming alcohol, must be willing to stay on a stable amount throughout the study period and to log alcohol consumption.
• In good general health at the time of screening (Investigator discretion).
• Able to read and understand English.
• Able to read, understand, and provide informed consent.
• Able to use a personal smartphone device and laptop, download Chloe by People Science and use the BrainHQ web-based assessment platform.
• Able to receive shipment of the product at an address within the United States.
• Able to complete study assessments over the course of up to 9 weeks.

Exclusion criteria

• Any potential participants who:
• Do not have a smartphone and/or internet access.
• Concomitant Therapies:
• Participants taking prescription medication for sleep (e.g. Benzodiazepines, zolpidem, zaleplon) not on a stable dose for at least 4 weeks
• Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
• Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
• Other Illnesses or Conditions: Participants who have the following conditions or comorbidities are excluded:
• Diagnosis of Alzheimer's disease or dementia
• Diagnosed neurological condition or assessed as having a learning/behavioural or neurodevelopmental difference such as dyslexia or ADHD
• Have a visual impairment that cannot be corrected with glasses or contact lenses, including red green color blindness
• Deafness or untreated age-related hearing loss
• Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
• Current or prior history of psychotic disorder
• Diagnosed with Alcohol or Substance Abuse Disorder
• Currently pregnant, planning to become pregnant at any time during the study, or breastfeeding
• Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the trial or impact the trial outcomes
• Long Covid including persistent feelings of brain fog
• Participants using any nicotine and cannabis-containing products
• Known hypersensitivity or previous allergic reaction to Lion's mane or functional mushrooms.
• Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.