Psilocybin Effect on Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients

We are looking to improve the quality of life for people with autism. It’s the fastest growing developmental disability in the world, increasing at a rate of 10-17% each year, and many struggle to find effective treatment options.  

Fragile X Syndrome (FXS) is a genetic neurological disorder caused by a mutation on the X chromosome in the Fragile X messenger ribonucleoprotein 1 (FMR1) gene, typically due to the expansion of the CGG repeat.  Approximately 1 in 7000 males and 1 in 11,000 females are affected with FXS. Fragile X syndrome is associated with a range of developmental problems, such as learning disabilities, cognitive impairments, mood instability, compulsive disorders and sensory hypersensitivity. Many children also exhibit autism spectrum symptoms such as poor eye contact, shyness and hand-flapping. This diverse range of symptoms makes FXS difficult to treat. A novel therapy to help treat some of these symptoms with oral microdose psilocybin therapy is under investigation.  

Psilocybin is a naturally-occurring psychedelic that is produced by more than 200 species of fungi (mushrooms). Psilocybin is a serotonin agonist and activates the serotonin receptor 5-HT2A. We know that serotonin levels are much lower in ASD and FXS children and they miss key peak levels needed for normal brain development. 

We believe that serotonergic insufficiency during childhood may have a compounding effect on brain patterning in ASD and FXS, manifesting as behavioural and emotional symptoms. Psilocybin is expected to mimic serotonergic signaling when innate serotonin synthesis is low, as is common in developmental delay. 

Psilocybin has low risk for physical or psychological dependence and is not generally considered to be toxic even at high doses. 

 Psilocybin at microdose levels is proposed to be a first-in-class treatment for FXS. A microdose is approximately one-tenth of a full dose. 

 We believe that repetitive microdosing could provide greater benefits, as compared to full-dose interventions, with less risk of adverse reactions and without the hallucinogenic effects experienced with higher doses. 

Micro-dosing of psilocybin has been shown to improve depression, anxiety and addictions offering a more holistic approach to therapy. Psilocybin may help improve brain plasticity and reduce anxiety and behavioural rigidity. (Do you have articles showing the effect of microdosing in depression, anxiety, and addictions?) 

 Other treatments for FXS involve pharmaceutical and behavioural interventions. Psilocybin provides a potential alternative that may be able to improve cognition, communication, mood, and behaviour problems as well as other possible benefits.  

This study will be an open-label, single arm 28-day study with the intent to study the effects on behavioural and cognitive impairments. Visits to the clinic will occur weekly and all initial doses will be started at the KGK Science clinic under medical supervision to watch for adverse effects. 

Paid compensation of up to $ 750 for each qualified participant upon completion of this study. 

Eligible participants will need to be: 

• Adults diagnosed with Fragile X Syndrome 
• Willing to take microdoses of Psilocybin. 
• Ability to swallow tablets/Capsules. 
• Relatively Healthy Individual 
• Interested in helping to advance Fragile X Syndrome treatments 

If interested in participating in this study, sign up now to be added to our waiting list. 

Click Here to Complete the Eligibility Questionnaire  

Have any questions about this study?

Please email us participate@kgkscience.com

or

Call us at 1-833-858-8359

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