<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/NCT03299062</url>
  </required_header>
  <id_info>
    <org_study_id>206829</org_study_id>
    <nct_id>NCT03299062</nct_id>
  </id_info>
  <brief_title>Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders</brief_title>
  <official_title>Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Degenerative dementias including Alzheimer's Disease (AD), Parkinson's Disease with Dementia&#xD;
      (PDD), Dementia with Lewy Bodies (DLB), Frontotemporal Dementias (FTLD), Corticobasal&#xD;
      Degeneration (CBD) and Progressive Supranuclear Palsy (PSP) constitute a significant, and&#xD;
      growing burden with an estimated cost to the US healthcare system for 2016 of $236 Billion&#xD;
      (1). Definitive diagnosis of these dementias is based on pathological criterion upon autopsy,&#xD;
      which presents a significant challenge to establish diagnosis in living patients. Although&#xD;
      clinical diagnostic criteria have been developed for several of these disorders, including&#xD;
      for Alzheimer's Disease (AD) by the National Institute of Neurological and Communicative&#xD;
      Disorders and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA)&#xD;
      , Parkinson's Disease (PD) by the United Kingdom Parkinson Disease Brain Bank Diagnostic&#xD;
      Criteria (UKPDBB) diagnostic criteria for Parkinson Disease(4) and others, the currently&#xD;
      available tests, including the use of imaging markers and Cerebrospinal Fluid (CSF)&#xD;
      biological markers do not provide a definite diagnosis since this requires the observation of&#xD;
      characteristic neuropathological changes in specific regions of the brain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alpha-synuclein Levels From Nasal Swabs</measure>
    <time_frame>Up to 4 weeks after swab is completed</time_frame>
    <description>Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, Amyloid-beta (A-beta) and Phospho-tau (p-tau) staining.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Neurodegenerative Diseases</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease with Voice Dysfunction Patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>• Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other Neurodegenerative Disorders with Voice Dysfunction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>• Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voice Dysfunction</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twenty people with voice tremor and/or presbylarynx, but no evidence of Parkinson's other neurodegenerative disease, requiring evaluation of voice dysfunction by an ENT doctor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cytology and Immunohistochemistry</intervention_name>
    <description>Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.</description>
    <arm_group_label>Other Neurodegenerative Disorders with Voice Dysfunction</arm_group_label>
    <arm_group_label>Parkinson's Disease with Voice Dysfunction Patients</arm_group_label>
    <arm_group_label>Voice Dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with idiopathic Parkinson's disease, progressive supranuclear palsy,&#xD;
             Alzheimer's disease or Mild Cognitive Impairment based on consensus criteria, or&#xD;
             suspicion of presbylarynx based on clinical evaluation.&#xD;
&#xD;
          -  Require evaluation of voice dysfunction by an ENT doctor given symptoms of impaired&#xD;
             voice volume or quality&#xD;
&#xD;
          -  Age ≥ 18 years-old to ≤ 90-years old.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Active nose bleeds, or abnormal anatomy of the nose that prevent safe nasal swabs, or&#xD;
             active oropharyngeal disease that prevents laryngoscopy or voice assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rohit Dhall, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <results_first_submitted>September 28, 2022</results_first_submitted>
  <results_first_submitted_qc>October 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 25, 2022</results_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03299062/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03299062/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Parkinson's Disease With Voice Dysfunction Patients</title>
          <description>• Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor&#xD;
Cytology and Immunohistochemistry: Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.</description>
        </group>
        <group group_id="P2">
          <title>Other Neurodegenerative Disorders With Voice Dysfunction</title>
          <description>• Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.&#xD;
Cytology and Immunohistochemistry: Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrollment was stopped due to COVID-19 pandemic after 4 subjects with PD and 5 with other neurodegenerative disorders with voice dysfunction were enrolled.</population>
      <group_list>
        <group group_id="B1">
          <title>Parkinson's Disease With Voice Dysfunction Patients</title>
          <description>• Enrollment was stopped due to COVID-19 pandemic after 4 people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor were enrolled.&#xD;
Cytology and Immunohistochemistry: Samples from 1 subject were processed for GFAP and S100 staining to confirm presence of olfactory neuronal tissue.</description>
        </group>
        <group group_id="B2">
          <title>Other Neurodegenerative Disorders With Voice Dysfunction</title>
          <description>• Enrollment was stopped due to COVID-19 pandemic after 5 people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.&#xD;
Cytology and Immunohistochemistry: No samples were processed for this group.</description>
        </group>
        <group group_id="B3">
          <title>Voice Dysfunction</title>
          <description>No subjects were enrolled in this arm.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Alpha-synuclein Levels From Nasal Swabs</title>
        <description>Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, Amyloid-beta (A-beta) and Phospho-tau (p-tau) staining.</description>
        <time_frame>Up to 4 weeks after swab is completed</time_frame>
        <population>Due to early termination of subject enrollment, there were an insufficient number of samples to process for this analysis. As such, none of the samples were (or will be) analyzed for the outcome measures listed and therefore there are no results to report beyond participant flow.</population>
        <group_list>
          <group group_id="O1">
            <title>Parkinson's Disease With Voice Dysfunction Patients</title>
            <description>• Enrollment was stopped due to COVID-19 pandemic after 4 people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor were enrolled.&#xD;
Cytology and Immunohistochemistry: Although samples from 1 subject were processed for GFAP and S100 staining to confirm presence of olfactory neuronal tissue, none of the samples were (or will be) analyzed for the outcome measures listed and therefore there are no results to report beyond participant flow.</description>
          </group>
          <group group_id="O2">
            <title>Other Neurodegenerative Disorders With Voice Dysfunction</title>
            <description>• Enrollment was stopped due to COVID-19 pandemic after 5 people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.&#xD;
Cytology and Immunohistochemistry: No samples were processed for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Alpha-synuclein Levels From Nasal Swabs</title>
          <description>Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, Amyloid-beta (A-beta) and Phospho-tau (p-tau) staining.</description>
          <population>Due to early termination of subject enrollment, there were an insufficient number of samples to process for this analysis. As such, none of the samples were (or will be) analyzed for the outcome measures listed and therefore there are no results to report beyond participant flow.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The study was done in a single session for each participant, typically taking 4 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Parkinson's Disease With Voice Dysfunction Patients</title>
          <description>Subjects with Parkinson's Disease with Voice Dysfunction Patients</description>
        </group>
        <group group_id="E2">
          <title>Other Neurodegenerative Disorders With Voice Dysfunction</title>
          <description>Subjects with other Neurodegenerative Disorders with Voice Dysfunction</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to lack of enrollment, and the COVID-19 pandemic, the analysis of biospecimens was not performed. None of the collected samples from this study were analyzed for the outcome measures in this record, and therefore there are no results to report beyond participant flow.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rohit Dhall, MD</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>6025033193</phone>
      <email>rdhall@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03299062
org study id: 206829
nct id: NCT03299062
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Degenerative dementias including Alzheimer's Disease (AD), Parkinson's Disease with Dementia
      (PDD), Dementia with Lewy Bodies (DLB), Frontotemporal Dementias (FTLD), Corticobasal
      Degeneration (CBD) and Progressive Supranuclear Palsy (PSP) constitute a significant, and
      growing burden with an estimated cost to the US healthcare system for 2016 of $236 Billion
      (1). Definitive diagnosis of these dementias is based on pathological criterion upon autopsy,
      which presents a significant challenge to establish diagnosis in living patients. Although
      clinical diagnostic criteria have been developed for several of these disorders, including
      for Alzheimer's Disease (AD) by the National Institute of Neurological and Communicative
      Disorders and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA)
      , Parkinson's Disease (PD) by the United Kingdom Parkinson Disease Brain Bank Diagnostic
      Criteria (UKPDBB) diagnostic criteria for Parkinson Disease(4) and others, the currently
      available tests, including the use of imaging markers and Cerebrospinal Fluid (CSF)
      biological markers do not provide a definite diagnosis since this requires the observation of
      characteristic neuropathological changes in specific regions of the brain.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Alpha-synuclein Levels From Nasal Swabs
time frame: Up to 4 weeks after swab is completed
description: Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, Amyloid-beta (A-beta) and Phospho-tau (p-tau) staining.
arm group label: Parkinson's Disease with Voice Dysfunction Patients
arm group type: Active Comparator
description: • Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor
arm group label: Other Neurodegenerative Disorders with Voice Dysfunction
arm group type: Active Comparator
description: • Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.
arm group label: Voice Dysfunction
arm group type: Placebo Comparator
description: Twenty people with voice tremor and/or presbylarynx, but no evidence of Parkinson's other neurodegenerative disease, requiring evaluation of voice dysfunction by an ENT doctor.
intervention type: Diagnostic Test
intervention name: Cytology and Immunohistochemistry
description: Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.
arm group label: Other Neurodegenerative Disorders with Voice Dysfunction
arm group label: Parkinson's Disease with Voice Dysfunction Patients
arm group label: Voice Dysfunction
criteria: 
gender: All
minimum age: 19 Years
maximum age: 89 Years
healthy volunteers: No
last name: Rohit Dhall, MD, MSPH
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Neurodegenerative Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to lack of enrollment, and the COVID-19 pandemic, the analysis of biospecimens was not performed. None of the collected samples from this study were analyzed for the outcome measures in this record, and therefore there are no results to report beyond participant flow.
point of contact: 