xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06041152</url>
    </required_header>
    <id_info>
      <org_study_id>101-2021</org_study_id>
      <nct_id>NCT06041152</nct_id>
    </id_info>
    <brief_title>Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment</brief_title>
    <official_title>Does Psilocybin Change Synaptic Density in the Brains of Patients With Amnestic Mild Cognitive Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre for Addiction and Mental Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre for Addiction and Mental Health</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to investigate the effects of psilocybin on synaptic&#xD;
        vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer,&#xD;
        18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy&#xD;
        participants. The investigators hypothesize that SVD levels in the brain will be higher&#xD;
        following the ingestion of psilocybin in comparison to placebo, and that increases in SVD&#xD;
        will be associated with improvements in cognition.&#xD;
  &#xD;
        60 participants (30 with aMCI, and 30 sex and age matched healthy volunteers) will:&#xD;
  &#xD;
          -  Be randomized to receive either:&#xD;
  &#xD;
               1. Two 25 mg macrodoses of psilocybin separated by 1 week.&#xD;
  &#xD;
               2. Two placebo doses separated by 1 week.&#xD;
  &#xD;
          -  Receive a baseline 18F-SynVesT-1 PET scan, clinical, and neuropsychological assessments.&#xD;
  &#xD;
          -  Receive a 18F-SynVesT-1 PET scan one week after the last dose of treatment.&#xD;
  &#xD;
          -  Receive a third PET scan at any time within 4 weeks of the screening visit to quantify&#xD;
             tauopathy with the [18F]T807 radiotracer.&#xD;
  &#xD;
          -  Receive clinical and neuropsychological testing 1, 4, and 12 weeks after the last&#xD;
             treatment.&#xD;
  &#xD;
        Researchers will compare placebo vs. experimental groups to see if psilocybin will increase&#xD;
        SVD, and if increases in SVD are associated with cognitive improvements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed study will investigate the effects of on synaptic vesicular density (SVD) levels&#xD;
        as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, and&#xD;
        cognition (i.e., global cognition, executive function, and memory domains) in amnestic Mild&#xD;
        Cognitive Impairment (aMCI) and healthy participants. Participants will be randomized to&#xD;
        receive either two 25mg doses of psilocybin separated by one week, or two placebo doses&#xD;
        separated by one week. Brain scans, clinical, and cognitive assessments will be conducted one&#xD;
        week before, and one week, four weeks, and 12 weeks post dosing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Synaptic Vesicular Density</measure>
      <time_frame>3 years</time_frame>
      <description>Synaptic vesicular density will be assessed with PET imaging by measuring the volume of distribution (i.e., defined as the ratio of the radioligand concentration in tissue target region (CT, kBq·cm-3) to that in plasma (CP, kBq·mL-1) at equilibrium) of the [18F]SynVesT-1 radioligand in the cortical and subcortical gray matter regions in the whole brain and more specifically, the hippocampus and dorsolateral prefrontal cortex.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Global Cognition</measure>
      <time_frame>3 years</time_frame>
      <description>The results of the neuropsychological battery will be combined to a global cognition composite score as a Z-score, the change of which will be a secondary outcome measure. Z-scores will be comprised of the Mini-Mental State Examination, Montreal Cognitive Assessment, Boston Naming Test, Category Fluency Test, Letter Fluency Test, Trail Making Test Parts A and B, Wisconsin Card Sorting Test, Stroop Neuropsychological Test, Executive Interview, Block Design Test, Clock Drawing Test, Grooved Pegboard, Digit Symbol Test, Logical Memory Test, California Verbal Learning Test, and Modified Rey-Osterrieth Complex Figure, and will be calculated based on the performance of the equated comparison group. Each domain will contribute equally to the global cognition composite score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Memory</measure>
      <time_frame>3 years</time_frame>
      <description>A memory composite Z-score will be generated using the performance on the following individual tests: Logical Memory Test, California Verbal Learning Test, and Modified Rey-Osterrieth Complex Figure. Z-scores will be calculated based on the performance of the equated comparison group, and each domain will contribute equally to the global cognition composite score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Executive Function</measure>
      <time_frame>3 years</time_frame>
      <description>An executive function composite Z-score will be generated using the performance on the following individual tests: Trail Making Test Part B, Wisconsin Card Sorting Test, Stroop Neuropsychological Screening, and the Executive Interview. Z-scores will be calculated based on the performance of the equated comparison group, and each domain will contribute equally to the global cognition composite score.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Exploratory Cognitive Outcomes</measure>
      <time_frame>3 years</time_frame>
      <description>If individual cognitive test scores are significantly different between groups, the mean difference of the individual test scores (i.e., Mini-Mental State Examination, Montreal Cognitive Assessment, Boston Naming Test, Category Fluency Test, Letter Fluency Test, Trail Making Test Parts A and B, Wisconsin Card Sorting Test, Stroop Neuropsychological Test, Executive Interview, Block Design Test, Clock Drawing Test, Grooved Pegboard, Digit Symbol Test, Logical Memory Test, California Verbal Learning Test, and Modified Rey-Osterrieth Complex Figure) will be analyzed separately as exploratory outcomes.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory Primary and Secondary Outcomes</measure>
      <time_frame>3 years</time_frame>
      <description>Primary and secondary outcomes will be compared between aMCI and healthy control groups.&#xD;
  The means of the primary outcome (i.e., volume of distribution) and secondary outcomes (i.e., cognitive composite Z-scores: global cognition, memory, and executive function) will be compared between aMCI and healthy control groups.</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Amnestic Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Amnestic Mild Cognitive Impairment Participants Receiving Psilocybin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Receiving 2 doses of 25mg of psilocybin separated by 1 week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Participants Receiving Psilocybin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Receiving 2 doses of 25mg of psilocybin separated by 1 week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Amnestic Mild Cognitive Impairment Participants Receiving Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Receiving 2 doses of placebo separated by 1 week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Participants Receiving Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Receiving 2 doses of placebo separated by 1 week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Psilocybin</intervention_name>
      <description>2 macrodoses of 25mg separated by one week.</description>
      <arm_group_label>Amnestic Mild Cognitive Impairment Participants Receiving Psilocybin</arm_group_label>
      <arm_group_label>Healthy Participants Receiving Psilocybin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>2 doses of placebo separated by one week.</description>
      <arm_group_label>Amnestic Mild Cognitive Impairment Participants Receiving Placebo</arm_group_label>
      <arm_group_label>Healthy Participants Receiving Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          The aMCI participant must meet all of the inclusion criteria to be eligible for this&#xD;
          clinical trial:&#xD;
  &#xD;
            1. Male or female participants of any race or ethnicity&#xD;
  &#xD;
            2. Inpatients or outpatients 60 to 75 years of age (on day of randomization)&#xD;
  &#xD;
            3. Diagnosis of MCI based on DSM 5 diagnostic criteria of Minor Neurocognitive Disorder&#xD;
  &#xD;
            4. Categorization of episodic memory impairment based on scores ≥ 1.0 SD lower on any of&#xD;
               the following measures in comparison to normative data i. Logical Memory Test (62),&#xD;
               ii. California Verbal Learning Test (63), iii. Modified Rey-Osterrieth Complex Figure&#xD;
               (64).&#xD;
  &#xD;
            5. Non-smoker/Non-nicotine user&#xD;
  &#xD;
            6. Montreal Cognitive Assessment (MoCA) score = &lt; 26 and MMSE score &gt; = 24&#xD;
  &#xD;
            7. Capable of consenting to participate in the research study&#xD;
  &#xD;
            8. On a stable dose of medication for at least 2 months [see section 5.6], and unlikely&#xD;
               to undergo changes in dose during the study&#xD;
  &#xD;
            9. Availability of a study partner who has regular contact with the participant&#xD;
  &#xD;
           10. Ability to read and communicate in English (with corrected vision and hearing, if&#xD;
               needed)&#xD;
  &#xD;
          The Healthy Control participant must meet all of the inclusion criteria to be eligible for&#xD;
          this clinical trial:&#xD;
  &#xD;
            1. Male or female participants of any race or ethnicity&#xD;
  &#xD;
            2. 60 to 75 years of age (on day of randomization)&#xD;
  &#xD;
            3. Does not meet SCID-5 criteria for Mild Neurocognitive Disorder, Alzheimer's disease,&#xD;
               or other major neurocognitive disorder&#xD;
  &#xD;
            4. Non-smoker/Non-nicotine user&#xD;
  &#xD;
            5. Capable of consenting to participate in the research study&#xD;
  &#xD;
            6. On a stable dose of medication for at least 2 months [see section 5.6], and unlikely&#xD;
               to undergo changes in dose during the study&#xD;
  &#xD;
            7. Availability of a study partner who has regular contact with the participant&#xD;
  &#xD;
            8. Ability to read and communicate in English (with corrected vision and hearing, if&#xD;
               needed)&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          An individual who meets any of the following criteria will be excluded from participation&#xD;
          in this clinical trial:&#xD;
  &#xD;
            1. Unwilling or incapable to consent to the study&#xD;
  &#xD;
            2. Unstable medical or any concomitant major medical or neurological illness, including&#xD;
               presence of a relative or absolute contraindication to psilocybin, i.e. a drug&#xD;
               allergy, recent stroke history, uncontrolled hypertension, low or labile blood&#xD;
               pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery&#xD;
               disease, or moderate to severe renal or hepatic impairment.&#xD;
  &#xD;
            3. History of head trauma resulting in loss of consciousness &gt; 30 minutes that required&#xD;
               medical attention.&#xD;
  &#xD;
            4. DSM-5 diagnosis, with active symptoms in the last three months, of major depression;&#xD;
               lifetime diagnosis of bipolar disorder; intellectual disability; Alzheimer's Disease;&#xD;
               or a psychotic disorder&#xD;
  &#xD;
            5. DSM-5 substance dependence (except caffeine) within 12 months of entering the study&#xD;
  &#xD;
            6. Anticonvulsant, antidepressant, antipsychotic, mood stabilizer, opioid, or&#xD;
               benzodiazepine use&#xD;
  &#xD;
            7. Lifetime use of serotonergic psychedelic drugs&#xD;
  &#xD;
            8. Positive urine drug screen at the screening visit&#xD;
  &#xD;
            9. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within&#xD;
               the past 6 weeks&#xD;
  &#xD;
           10. Acute suicidal or homicidal ideation&#xD;
  &#xD;
           11. Receiving treatment with medications such as levetiracetam that blocks SV2a binding,&#xD;
               and/or inability to discontinue the following medications before study drug dosing:&#xD;
               inhibitors of uridine 5'-diphospho-glucuronosyltransferase (UGT)1A9 and (UGT)1A10, and&#xD;
               ALDH inhibitors and alcohol dehydrogenase (ADH) inhibitors.&#xD;
  &#xD;
           12. Exceeding allowed annual radiation exposure levels (20 mSv), as outlined by our PET&#xD;
               Centre guidelines&#xD;
  &#xD;
           13. Disorders of coagulation or taking anticoagulant medication&#xD;
  &#xD;
           14. Having completed multiple PET scans in the past, such that participation in this study&#xD;
               would cause participant to exceed lifetime limit (8 PET scans)&#xD;
  &#xD;
           15. Metal implants or pacemaker precluding an MRI scan or other contraindications to MRI&#xD;
               (e.g., claustrophobia)&#xD;
  &#xD;
           16. Female with childbearing potential*, pregnancy (as confirmed by a negative pregnancy&#xD;
               test) or breastfeeding&#xD;
  &#xD;
           17. Active gender affirming hormonal treatment&#xD;
  &#xD;
           18. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder;&#xD;
               psychotic disorder (unless substance-induced or due to a medical condition); or&#xD;
               bipolar I or II disorder as determined by the family medical history form and&#xD;
               discussions with the participant.&#xD;
  &#xD;
           19. Allergies to hydroxypropyl methylcellulose *A woman/female or person who is not of&#xD;
               childbearing potential is considered to be postmenopausal after at least 12 months&#xD;
               without menstruation. Postmenopausal is defined as 12 consecutive months with no&#xD;
               menses without an alternative medical cause. Females/people of childbearing potential&#xD;
               are those who have experienced menarche and do not meet the criteria for women not of&#xD;
               childbearing potential.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Philip Gerretsen, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre for Addiction and Mental Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Philip Gerretsen, MD, PhD</last_name>
      <phone>416-535-8501</phone>
      <phone_ext>39426</phone_ext>
      <email>philip.gerretsen@camh.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ariel Graff, MD, PhD</last_name>
      <phone>416-535-8501</phone>
      <phone_ext>34834</phone_ext>
      <email>ariel.graff@camh.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre for Addiction and Mental Health</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5T 1R8</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <link>
      <url>https://www.camh.ca/en/science-and-research</url>
      <description>The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
      <investigator_full_name>Philip Gerretsen</investigator_full_name>
      <investigator_title>Clinician Scientist</investigator_title>
    </responsible_party>
    <keyword>amnestic mild cognitive impairment</keyword>
    <keyword>psilocybin</keyword>
    <keyword>SV2A</keyword>
    <keyword>positron emission tomography</keyword>
    <keyword>synaptic vesicular density</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psilocybin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06041152
  org study id: 101-2021
  nct id: NCT06041152
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the effects of psilocybin on synaptic
        vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer,
        18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy
        participants. The investigators hypothesize that SVD levels in the brain will be higher
        following the ingestion of psilocybin in comparison to placebo, and that increases in SVD
        will be associated with improvements in cognition.
  
        60 participants (30 with aMCI, and 30 sex and age matched healthy volunteers) will:
  
          -  Be randomized to receive either:
  
               1. Two 25 mg macrodoses of psilocybin separated by 1 week.
  
               2. Two placebo doses separated by 1 week.
  
          -  Receive a baseline 18F-SynVesT-1 PET scan, clinical, and neuropsychological assessments.
  
          -  Receive a 18F-SynVesT-1 PET scan one week after the last dose of treatment.
  
          -  Receive a third PET scan at any time within 4 weeks of the screening visit to quantify
             tauopathy with the [18F]T807 radiotracer.
  
          -  Receive clinical and neuropsychological testing 1, 4, and 12 weeks after the last
             treatment.
  
        Researchers will compare placebo vs. experimental groups to see if psilocybin will increase
        SVD, and if increases in SVD are associated with cognitive improvements.
  The proposed study will investigate the effects of on synaptic vesicular density (SVD) levels
        as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, and
        cognition (i.e., global cognition, executive function, and memory domains) in amnestic Mild
        Cognitive Impairment (aMCI) and healthy participants. Participants will be randomized to
        receive either two 25mg doses of psilocybin separated by one week, or two placebo doses
        separated by one week. Brain scans, clinical, and cognitive assessments will be conducted one
        week before, and one week, four weeks, and 12 weeks post dosing.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Synaptic Vesicular Density
  time frame: 3 years
  description: Synaptic vesicular density will be assessed with PET imaging by measuring the volume of distribution (i.e., defined as the ratio of the radioligand concentration in tissue target region (CT, kBq·cm-3) to that in plasma (CP, kBq·mL-1) at equilibrium) of the [18F]SynVesT-1 radioligand in the cortical and subcortical gray matter regions in the whole brain and more specifically, the hippocampus and dorsolateral prefrontal cortex.
  measure: Global Cognition
  time frame: 3 years
  description: The results of the neuropsychological battery will be combined to a global cognition composite score as a Z-score, the change of which will be a secondary outcome measure. Z-scores will be comprised of the Mini-Mental State Examination, Montreal Cognitive Assessment, Boston Naming Test, Category Fluency Test, Letter Fluency Test, Trail Making Test Parts A and B, Wisconsin Card Sorting Test, Stroop Neuropsychological Test, Executive Interview, Block Design Test, Clock Drawing Test, Grooved Pegboard, Digit Symbol Test, Logical Memory Test, California Verbal Learning Test, and Modified Rey-Osterrieth Complex Figure, and will be calculated based on the performance of the equated comparison group. Each domain will contribute equally to the global cognition composite score.
  measure: Memory
  time frame: 3 years
  description: A memory composite Z-score will be generated using the performance on the following individual tests: Logical Memory Test, California Verbal Learning Test, and Modified Rey-Osterrieth Complex Figure. Z-scores will be calculated based on the performance of the equated comparison group, and each domain will contribute equally to the global cognition composite score.
  measure: Executive Function
  time frame: 3 years
  description: An executive function composite Z-score will be generated using the performance on the following individual tests: Trail Making Test Part B, Wisconsin Card Sorting Test, Stroop Neuropsychological Screening, and the Executive Interview. Z-scores will be calculated based on the performance of the equated comparison group, and each domain will contribute equally to the global cognition composite score.
  measure: Exploratory Cognitive Outcomes
  time frame: 3 years
  description: If individual cognitive test scores are significantly different between groups, the mean difference of the individual test scores (i.e., Mini-Mental State Examination, Montreal Cognitive Assessment, Boston Naming Test, Category Fluency Test, Letter Fluency Test, Trail Making Test Parts A and B, Wisconsin Card Sorting Test, Stroop Neuropsychological Test, Executive Interview, Block Design Test, Clock Drawing Test, Grooved Pegboard, Digit Symbol Test, Logical Memory Test, California Verbal Learning Test, and Modified Rey-Osterrieth Complex Figure) will be analyzed separately as exploratory outcomes.
  measure: Exploratory Primary and Secondary Outcomes
  time frame: 3 years
  description: Primary and secondary outcomes will be compared between aMCI and healthy control groups.
  The means of the primary outcome (i.e., volume of distribution) and secondary outcomes (i.e., cognitive composite Z-scores: global cognition, memory, and executive function) will be compared between aMCI and healthy control groups.
  arm group label: Amnestic Mild Cognitive Impairment Participants Receiving Psilocybin
  arm group type: Experimental
  description: Receiving 2 doses of 25mg of psilocybin separated by 1 week.
  arm group label: Healthy Participants Receiving Psilocybin
  arm group type: Experimental
  description: Receiving 2 doses of 25mg of psilocybin separated by 1 week.
  arm group label: Amnestic Mild Cognitive Impairment Participants Receiving Placebo
  arm group type: Placebo Comparator
  description: Receiving 2 doses of placebo separated by 1 week.
  arm group label: Healthy Participants Receiving Placebo
  arm group type: Placebo Comparator
  description: Receiving 2 doses of placebo separated by 1 week.
  intervention type: Drug
  intervention name: Psilocybin
  description: 2 macrodoses of 25mg separated by one week.
  arm group label: Amnestic Mild Cognitive Impairment Participants Receiving Psilocybin
  arm group label: Healthy Participants Receiving Psilocybin
  intervention type: Drug
  intervention name: Placebo
  description: 2 doses of placebo separated by one week.
  arm group label: Amnestic Mild Cognitive Impairment Participants Receiving Placebo
  arm group label: Healthy Participants Receiving Placebo
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Philip Gerretsen, MD, PhD
  role: Principal Investigator
  affiliation: Centre for Addiction and Mental Health
  last name: Philip Gerretsen, MD, PhD
  phone: 416-535-8501
  phone ext: 39426
  email: philip.gerretsen@camh.ca
  last name: Ariel Graff, MD, PhD
  phone: 416-535-8501
  phone ext: 34834
  email: ariel.graff@camh.ca
  facility: 
  country: Canada
  url: https://www.camh.ca/en/science-and-research
  description: The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.
  responsible party type: Principal Investigator
  investigator affiliation: Centre for Addiction and Mental Health
  investigator full name: Philip Gerretsen
  investigator title: Clinician Scientist
  mesh term: Cognitive Dysfunction
  mesh term: Psilocybin
  sharing ipd: No