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Study on Lion's Mane Product for Cognitive Health

This study is looking at how a Lion's Mane product, a dietary supplement, affects memory, focus, and other brain functions in people who feel their memory is declining. Researchers want to see if this product helps with attention, short-term memory, and working memory. You might be able to join if you are between 40 and 75 years old and have noticed some changes in your memory or focus. The study will compare people who take the Lion's Mane product to those who take a placebo (an inactive substance). The goal is to understand the product's impact on cognitive function, mood, and sleep quality over an 8-week period.

Study design
This is an observational study planning to enroll 150 participants. It will compare the Lion's Mane product to a placebo.
What's involved
You will participate in a study lasting up to 14 weeks, which includes screening, a baseline period, and 8 weeks of using the product or placebo. You will complete assessments, scales, and surveys.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes related to attention and memory will be measured during the 14-week study period, which includes an 8-week product use period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06870136

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

Recruiting
Not specifiedAges 40–75Observational
M2 Ingredients
~150 participants
Updated 2025-03-11 on ClinicalTrials.gov
What's tested:Lion's Mane Study Product

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Impact on Attention, Short Term & Working Memory
Measured over Participants will complete up to a 14-week study consisting of screening period, randomization and shipping period, a baseline period, and an 8-week product/placebo use period.

Conditions

Cognitive Decline

Explore related trials

Cognitive Dysfunction

NCT06870136

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • People Science

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amy Kazaryan, MPhil · STUDY_DIRECTOR · People Science, Inc.

Who to contact

Amy Kazaryan, MPhil
[email protected]
8184528996
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Impact on Attention, Short Term & Working MemoryParticipants will complete up to a 14-week study consisting of screening period, randomization and shipping period, a baseline period, and an 8-week product/placebo use period.

    The primary outcome measure is to evaluate the impact of the Lion's Mane study product on a composite measure of Attention, Short Term \& Working Memory. This will be measured using the change from baseline in BrainHQ Cognitive Test Suite composite score at Week 8 between placebo and study product group.