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/NCT06002477</url>
    </required_header>
    <id_info>
      <org_study_id>230736</org_study_id>
      <nct_id>NCT06002477</nct_id>
    </id_info>
    <brief_title>Attentional Mechanisms in SCD</brief_title>
    <acronym>AMoCC-SCD</acronym>
    <official_title>Attentional Mechanisms of Cognitive Compensation in Subjective Cognitive Decline</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vanderbilt University Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will use an anticholinergic pharmacological probe to examine attention network&#xD;
        function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal&#xD;
        cognitive performance is maintained by compensatory attention network activity, supported by&#xD;
        enhanced cholinergic function. The investigators anticipate that SCD will be associated with&#xD;
        greater compensatory attention network activity and that disrupting this compensatory process&#xD;
        through anticholinergic challenge will result in a greater negative effect on attentional&#xD;
        performance (Attention Network Test, ANT) and attention network functioning (EEG) in older&#xD;
        adults with greater subjective cognitive concern.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Overview: Cognitively normal older adults with and without subjective cognitive decline (SCD)&#xD;
        (n = 80) will complete two study visits that will be double blinded and randomized for&#xD;
        anticholinergic challenge (mecamylamine or placebo). Drug challenge visits will include&#xD;
        cognitive testing and an electroencephalography (EEG) session.&#xD;
  &#xD;
        AIM 1: Test for anticholinergic effects on attentional network function by cognitive concern&#xD;
        severity. Under anticholinergic challenge, compared to placebo, greater subjective cognitive&#xD;
        concerns will be associated with…:&#xD;
  &#xD;
        Hyp. 1a: greater reduction in orienting attention network activity (ERP amplitude for early&#xD;
        attention orienting).&#xD;
  &#xD;
        Hyp. 1b: greater negative change in orienting attention performance.&#xD;
  &#xD;
        Screening Procedures:&#xD;
  &#xD;
        We will assure participants do not have MCI using the MoCA and GDS. Participants scoring&#xD;
        below 26 on the MoCA or above 3 on the GDS will be excluded.&#xD;
  &#xD;
        Medical history and comorbidity will be quantified using the Cumulative Illness Rating Scale&#xD;
        (CIRS) 90. Self-reported medical histories, and problem lists from electronic medical records&#xD;
        will be reviewed for excluded medication and illness. Vital signs (weight, and height) will&#xD;
        be assessed. Participants will complete an electrocardiogram and blood samples will be&#xD;
        collected for a comprehensive metabolic panel and thyroid stimulating hormone levels.&#xD;
  &#xD;
        All participants will be evaluated to exclude individuals with significant psychiatric&#xD;
        symptoms using a partial Structured Clinical Interview for DSM-IV-TR (SCID). Participants&#xD;
        will also complete the Beck Depression Rating Scale (BDI) and the Beck Anxiety Inventory&#xD;
        (BAI). Participants scoring above a BDI of 7 or a BAI of 15 will be excluded.&#xD;
  &#xD;
        Study Drug Administration: During challenge drug study visits, participants will receive&#xD;
        double-blinded administration of study drug (20 mg oral mecamylamine) or placebo. The order&#xD;
        of administration will be randomized across study days. Randomization and dispensing will be&#xD;
        managed by VUMC Investigational Drug Services.&#xD;
  &#xD;
        Mecamylamine is a centrally and peripherally active non-competitive antagonist of nicotine&#xD;
        (and presumably acetylcholine) at C6 (ganglionic) type nicotinic receptors. Peak cognitive&#xD;
        and physiologic effects occur by 2-3 hours and dissipate by 4-6 hours after oral&#xD;
        administration. At the doses to be used in this study, the expected physiologic effects of&#xD;
        mecamylamine include cycloplegia, mydriasis, drowsiness, partial amnesia, decreased bowel&#xD;
        motility, tachycardia and decreased salivation. We have used mecamylamine extensively in&#xD;
        clinical studies in identical doses to those proposed here.&#xD;
  &#xD;
        EEG: Each participant will be tested individually in a quiet private room. EEG signals will&#xD;
        be recorded using a 128-channel Geodesic sensor net (EGI, Inc., Eugene, OR). The net is made&#xD;
        of Ag/AgCl-coated carbon electrodes embedded in soft electrolytic sponges and arranged into a&#xD;
        net using elastomer strings. Each electrode is connected via carbon wiring to a&#xD;
        high-impedance (1MOhm) low-noise amplifier that provides analogue-to-digital (A/D) conversion&#xD;
        of the EEG signals.&#xD;
  &#xD;
        Prior to application, the net is soaked in warm saline (KCl) solution. The electrode&#xD;
        impedances will be kept at or below 40 kOhms. The use of high-impedance amplifiers minimizes&#xD;
        any decrease in signal-to-noise ratio and allows collection of high-quality data without&#xD;
        having to abrade the scalp, thus minimizing any discomfort and reducing infection risks.&#xD;
        Tests of this system reported no significant signal loss over a range of EEG frequencies.&#xD;
        Another advantage of this system is fast electrode application and impedance adjustments (&lt;&#xD;
        10 minutes). The EEG signals will be sampled every 4ms with filters set at 0.1 Hz - 100 Hz.&#xD;
        During data collection, all electrodes will be referred to vertex (Cz). EEG will be&#xD;
        continuously monitored and during periods of motor activity or inattention, stimulus&#xD;
        presentation will be suspended until behavior quiets. The entire recording session will last&#xD;
        approximately 30 minutes.&#xD;
  &#xD;
        Attention Network Test (15 minutes): A task designed to test three attentional networks: (1)&#xD;
        alerting, (2) orienting, and (3) executive control. The ANT combines attentional and spatial&#xD;
        cues with a flanker task (a central stimulus is flanked by distractors that can indicate the&#xD;
        same or opposite response to the central stimulus). On each trial a spatial cue is presented,&#xD;
        followed by an array of five arrows presented at either the top or the bottom of the computer&#xD;
        screen. The participant must indicate the direction of the central arrow in the array of&#xD;
        five.&#xD;
  &#xD;
        The cue that precedes the arrows can be non-existent, a center cue, a double cue (one&#xD;
        presented at each of the two possible target locations), or a spatial cue that&#xD;
        deterministically indicates the upcoming target location. The alerting network contrasts&#xD;
        performance (RT) with and without cues, the orienting network contrasts performance on the&#xD;
        task with a spatial or neutral cue, and executive control (conflict) is measured by assessing&#xD;
        interference from congruent and incongruent flankers.&#xD;
  &#xD;
        Incidental Memory Task (8 minutes): A passive incidental visual memory paradigm will be used&#xD;
        to evaluate changes in basic memory processes. Subjects will be asked to view a slide show of&#xD;
        novel color photographs depicting complex natural scenes. A small subset of the stimuli will&#xD;
        be presented repeatedly (x5) throughout the session; the rest will be shown once. To&#xD;
        encourage attention to the stimulus sequence, 20 attention probes (yellow smiley face) will&#xD;
        be presented throughout the test session and require a button press response.&#xD;
  &#xD;
        Cognitive Assessments: Following the EEG session participants will complete cognitive&#xD;
        assessments of memory, and psychomotor speed. Administration takes approximately 35 minutes.&#xD;
        Our group has significant experience using these tests in older adult populations. Tests will&#xD;
        be administered in the order indicated below. Participants will be trained to stable&#xD;
        performance in the cognitive tasks to reduce learning effects on the repeated testing.&#xD;
        Different versions of all tests will be used during training and at each administration to&#xD;
        minimize the likelihood of carryover effects.&#xD;
  &#xD;
        The tasks chosen are designed to assess a range of cognitive domains including multiple&#xD;
        attention, and visual-spatial and verbal memory processes, as well as psychomotor speed.&#xD;
        These tasks will be completed under placebo and anticholinergic challenge. The cognitive&#xD;
        battery will assess 1)Attention Capacity: Multiple Object Tracking, Digit Symbol Coding; 2)&#xD;
        Attention Vigilance: Critical Flicker Fusion; 3)Psychomotor Speed: Choice Reaction Time;&#xD;
        4)Visual Episodic Memory: Picture Sequence Memory Task (NIH Toolbox); 5)Verbal episodic&#xD;
        Memory: Buschke Selective reminding Task; 6)Visual-Spatial Working Memory: Visual-Spatial&#xD;
        N-Back. The time to complete the cognitive battery will be less than two hours which is well&#xD;
        within the 4-6-hour duration of effect of 10 mg mecamylamine.&#xD;
  &#xD;
        Statistical Analysis Plan:Power was calculated for the Aim1 primary outcome measure of&#xD;
        correlation between CCI score and anticholinergic challenge effect on ANT orienting P1&#xD;
        amplitude. With a sample size of n = 80 and alpha = 0.05, for a weak moderate correlation (r&#xD;
        = 0.40) we will have over 95% power. This sample size is also appropriate for the&#xD;
        resting-state fMRI analyses.&#xD;
  &#xD;
        AIM 1 examines anticholinergic challenge effects on:&#xD;
  &#xD;
        Hyp 1a: Peak P1 amplitude in parietal regions for Orienting trials of the Attention Network&#xD;
        Test (ANT)&#xD;
  &#xD;
        The primary ANT ERP measure will be P1 amplitude for the orienting trials in parietal&#xD;
        electrodes. The P1 ERP peak amplitude will be measured between 150 - 250 ms after spatial&#xD;
        orienting cue onset. Peak P1 amplitude measured between 150 - 250 ms after the non-spatial&#xD;
        cue will be used as the baseline P1 measure. Exploratory analyses will also examine peak P1&#xD;
        amplitude averaged across frontal electrodes and peak Executive P3 amplitude measured between&#xD;
        250 - 500 ms after executive incongruent target onset (compared to P3 amplitude for congruent&#xD;
        targets).&#xD;
  &#xD;
        Cognitive concern severity will be measured as the number of items endorsed on the 20 item&#xD;
        Cognitive Change Index (CCI).&#xD;
  &#xD;
        Hyp 1a will be analyzed using a linear mixed effects model analysis, with Orienting P1&#xD;
        amplitude as the dependent variable and drug challenge (mecamylamine or placebo), CCI score,&#xD;
        and their interaction, as fixed factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2028</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peak P1 amplitude for Orienting</measure>
      <time_frame>After administration of second drug challenge, approximately 72 hours</time_frame>
      <description>Peak P1 amplitude in parietal regions for Orienting trials of the Attention Network Test (ANT) dyrung anticholinergic challenge</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Subjective Cognitive Decline</condition>
    <arm_group>
      <arm_group_label>Anticholinergic Challenge</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will receive oral mecamylamine for 1 day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Challenge</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>All participants will receive oral placebo for 1 day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mecamylamine Challenge</intervention_name>
      <description>Mecamylamine 20 mg oral pill administered once</description>
      <arm_group_label>Anticholinergic Challenge</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo Comparator Challenge</intervention_name>
      <description>Matching placebo oral pill administered once</description>
      <arm_group_label>Placebo Challenge</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age ≥ 55&#xD;
  &#xD;
            2. Montreal Cognitive Assessment (MoCA) &gt; 25 AND Global Deterioration Scale (GDS) rating&#xD;
               &lt; 3&#xD;
  &#xD;
            3. Non-smokers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. medical contraindications to the drug challenge&#xD;
  &#xD;
            2. primary neurological disorder (such as stroke, epilepsy, etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paul Newhouse, MD</last_name>
      <role>Study Director</role>
      <affiliation>Vanderbilt University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kimberly Albert, PhD</last_name>
      <phone>6159364559</phone>
      <email>kimberly.albert@vumc.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vanderbilt University Medical Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37212</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
      <investigator_full_name>Kimberly Albert</investigator_full_name>
      <investigator_title>Research Assitant Professor, Psychiatry</investigator_title>
    </responsible_party>
    <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>Mecamylamine</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/NCT06002477
  org study id: 230736
  nct id: NCT06002477
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study will use an anticholinergic pharmacological probe to examine attention network
        function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal
        cognitive performance is maintained by compensatory attention network activity, supported by
        enhanced cholinergic function. The investigators anticipate that SCD will be associated with
        greater compensatory attention network activity and that disrupting this compensatory process
        through anticholinergic challenge will result in a greater negative effect on attentional
        performance (Attention Network Test, ANT) and attention network functioning (EEG) in older
        adults with greater subjective cognitive concern.
  Overview: Cognitively normal older adults with and without subjective cognitive decline (SCD)
        (n = 80) will complete two study visits that will be double blinded and randomized for
        anticholinergic challenge (mecamylamine or placebo). Drug challenge visits will include
        cognitive testing and an electroencephalography (EEG) session.
  
        AIM 1: Test for anticholinergic effects on attentional network function by cognitive concern
        severity. Under anticholinergic challenge, compared to placebo, greater subjective cognitive
        concerns will be associated with…:
  
        Hyp. 1a: greater reduction in orienting attention network activity (ERP amplitude for early
        attention orienting).
  
        Hyp. 1b: greater negative change in orienting attention performance.
  
        Screening Procedures:
  
        We will assure participants do not have MCI using the MoCA and GDS. Participants scoring
        below 26 on the MoCA or above 3 on the GDS will be excluded.
  
        Medical history and comorbidity will be quantified using the Cumulative Illness Rating Scale
        (CIRS) 90. Self-reported medical histories, and problem lists from electronic medical records
        will be reviewed for excluded medication and illness. Vital signs (weight, and height) will
        be assessed. Participants will complete an electrocardiogram and blood samples will be
        collected for a comprehensive metabolic panel and thyroid stimulating hormone levels.
  
        All participants will be evaluated to exclude individuals with significant psychiatric
        symptoms using a partial Structured Clinical Interview for DSM-IV-TR (SCID). Participants
        will also complete the Beck Depression Rating Scale (BDI) and the Beck Anxiety Inventory
        (BAI). Participants scoring above a BDI of 7 or a BAI of 15 will be excluded.
  
        Study Drug Administration: During challenge drug study visits, participants will receive
        double-blinded administration of study drug (20 mg oral mecamylamine) or placebo. The order
        of administration will be randomized across study days. Randomization and dispensing will be
        managed by VUMC Investigational Drug Services.
  
        Mecamylamine is a centrally and peripherally active non-competitive antagonist of nicotine
        (and presumably acetylcholine) at C6 (ganglionic) type nicotinic receptors. Peak cognitive
        and physiologic effects occur by 2-3 hours and dissipate by 4-6 hours after oral
        administration. At the doses to be used in this study, the expected physiologic effects of
        mecamylamine include cycloplegia, mydriasis, drowsiness, partial amnesia, decreased bowel
        motility, tachycardia and decreased salivation. We have used mecamylamine extensively in
        clinical studies in identical doses to those proposed here.
  
        EEG: Each participant will be tested individually in a quiet private room. EEG signals will
        be recorded using a 128-channel Geodesic sensor net (EGI, Inc., Eugene, OR). The net is made
        of Ag/AgCl-coated carbon electrodes embedded in soft electrolytic sponges and arranged into a
        net using elastomer strings. Each electrode is connected via carbon wiring to a
        high-impedance (1MOhm) low-noise amplifier that provides analogue-to-digital (A/D) conversion
        of the EEG signals.
  
        Prior to application, the net is soaked in warm saline (KCl) solution. The electrode
        impedances will be kept at or below 40 kOhms. The use of high-impedance amplifiers minimizes
        any decrease in signal-to-noise ratio and allows collection of high-quality data without
        having to abrade the scalp, thus minimizing any discomfort and reducing infection risks.
        Tests of this system reported no significant signal loss over a range of EEG frequencies.
        Another advantage of this system is fast electrode application and impedance adjustments (<
        10 minutes). The EEG signals will be sampled every 4ms with filters set at 0.1 Hz - 100 Hz.
        During data collection, all electrodes will be referred to vertex (Cz). EEG will be
        continuously monitored and during periods of motor activity or inattention, stimulus
        presentation will be suspended until behavior quiets. The entire recording session will last
        approximately 30 minutes.
  
        Attention Network Test (15 minutes): A task designed to test three attentional networks: (1)
        alerting, (2) orienting, and (3) executive control. The ANT combines attentional and spatial
        cues with a flanker task (a central stimulus is flanked by distractors that can indicate the
        same or opposite response to the central stimulus). On each trial a spatial cue is presented,
        followed by an array of five arrows presented at either the top or the bottom of the computer
        screen. The participant must indicate the direction of the central arrow in the array of
        five.
  
        The cue that precedes the arrows can be non-existent, a center cue, a double cue (one
        presented at each of the two possible target locations), or a spatial cue that
        deterministically indicates the upcoming target location. The alerting network contrasts
        performance (RT) with and without cues, the orienting network contrasts performance on the
        task with a spatial or neutral cue, and executive control (conflict) is measured by assessing
        interference from congruent and incongruent flankers.
  
        Incidental Memory Task (8 minutes): A passive incidental visual memory paradigm will be used
        to evaluate changes in basic memory processes. Subjects will be asked to view a slide show of
        novel color photographs depicting complex natural scenes. A small subset of the stimuli will
        be presented repeatedly (x5) throughout the session; the rest will be shown once. To
        encourage attention to the stimulus sequence, 20 attention probes (yellow smiley face) will
        be presented throughout the test session and require a button press response.
  
        Cognitive Assessments: Following the EEG session participants will complete cognitive
        assessments of memory, and psychomotor speed. Administration takes approximately 35 minutes.
        Our group has significant experience using these tests in older adult populations. Tests will
        be administered in the order indicated below. Participants will be trained to stable
        performance in the cognitive tasks to reduce learning effects on the repeated testing.
        Different versions of all tests will be used during training and at each administration to
        minimize the likelihood of carryover effects.
  
        The tasks chosen are designed to assess a range of cognitive domains including multiple
        attention, and visual-spatial and verbal memory processes, as well as psychomotor speed.
        These tasks will be completed under placebo and anticholinergic challenge. The cognitive
        battery will assess 1)Attention Capacity: Multiple Object Tracking, Digit Symbol Coding; 2)
        Attention Vigilance: Critical Flicker Fusion; 3)Psychomotor Speed: Choice Reaction Time;
        4)Visual Episodic Memory: Picture Sequence Memory Task (NIH Toolbox); 5)Verbal episodic
        Memory: Buschke Selective reminding Task; 6)Visual-Spatial Working Memory: Visual-Spatial
        N-Back. The time to complete the cognitive battery will be less than two hours which is well
        within the 4-6-hour duration of effect of 10 mg mecamylamine.
  
        Statistical Analysis Plan:Power was calculated for the Aim1 primary outcome measure of
        correlation between CCI score and anticholinergic challenge effect on ANT orienting P1
        amplitude. With a sample size of n = 80 and alpha = 0.05, for a weak moderate correlation (r
        = 0.40) we will have over 95% power. This sample size is also appropriate for the
        resting-state fMRI analyses.
  
        AIM 1 examines anticholinergic challenge effects on:
  
        Hyp 1a: Peak P1 amplitude in parietal regions for Orienting trials of the Attention Network
        Test (ANT)
  
        The primary ANT ERP measure will be P1 amplitude for the orienting trials in parietal
        electrodes. The P1 ERP peak amplitude will be measured between 150 - 250 ms after spatial
        orienting cue onset. Peak P1 amplitude measured between 150 - 250 ms after the non-spatial
        cue will be used as the baseline P1 measure. Exploratory analyses will also examine peak P1
        amplitude averaged across frontal electrodes and peak Executive P3 amplitude measured between
        250 - 500 ms after executive incongruent target onset (compared to P3 amplitude for congruent
        targets).
  
        Cognitive concern severity will be measured as the number of items endorsed on the 20 item
        Cognitive Change Index (CCI).
  
        Hyp 1a will be analyzed using a linear mixed effects model analysis, with Orienting P1
        amplitude as the dependent variable and drug challenge (mecamylamine or placebo), CCI score,
        and their interaction, as fixed factors.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Peak P1 amplitude for Orienting
  time frame: After administration of second drug challenge, approximately 72 hours
  description: Peak P1 amplitude in parietal regions for Orienting trials of the Attention Network Test (ANT) dyrung anticholinergic challenge
  arm group label: Anticholinergic Challenge
  arm group type: Experimental
  description: All participants will receive oral mecamylamine for 1 day
  arm group label: Placebo Challenge
  arm group type: Placebo Comparator
  description: All participants will receive oral placebo for 1 day
  intervention type: Drug
  intervention name: Mecamylamine Challenge
  description: Mecamylamine 20 mg oral pill administered once
  arm group label: Anticholinergic Challenge
  intervention type: Other
  intervention name: Placebo Comparator Challenge
  description: Matching placebo oral pill administered once
  arm group label: Placebo Challenge
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Paul Newhouse, MD
  role: Study Director
  affiliation: Vanderbilt University Medical Center
  last name: Kimberly Albert, PhD
  phone: 6159364559
  email: kimberly.albert@vumc.org
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University Medical Center
  investigator full name: Kimberly Albert
  investigator title: Research Assitant Professor, Psychiatry
  mesh term: Cognitive Dysfunction
  mesh term: Mecamylamine
  sharing ipd: No