Phase
Condition
Dementia
Memory Loss
Mental Disability
Treatment
Lion's Mane Study Product
Clinical Study ID
Ages 40-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 havechosen to use the study product
Willing to do a 4-week washout from any supplements for memory or cognitive functionprior to randomization
Willing to do a 4-week washout prior to randomization from supplements with mushroomcompounds or consuming mushrooms known to impact NGF. This includes but may not belimited to: Reishi (ganoderma lucidum), cordyceps (cordyceps militaris or cordycepssinensis), 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 atleast 4 weeks prior to enrollment. "Stable dose" is defined as no changes in dosageor frequency of the specified medications for at least 4 weeks prior to enrollmentand throughout the study period.
If regularly consuming alcohol, must be willing to stay on a stable amountthroughout 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 PeopleScience 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
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 30days prior to randomization.
Other Illnesses or Conditions: Participants who have the following conditions orcomorbidities are excluded:
Diagnosis of Alzheimer's disease or dementia
Diagnosed neurological condition or assessed as having a learning/behaviouralor neurodevelopmental difference such as dyslexia or ADHD
Have a visual impairment that cannot be corrected with glasses or contactlenses, including red green color blindness
Deafness or untreated age-related hearing loss
Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless LegSyndrome, 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 theprincipal investigator, may impact their ability to participate in the trial orimpact 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 orfunctional mushrooms.
Are unlikely for any reason to be able to comply with the trial or consideredunsuited for participation in the study by the Principal Investigator.
Study Design
Study Description
Connect with a study center
People Science
Los Angeles, California 90034
United StatesActive - Recruiting
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