<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/NCT03290274</url>
  </required_header>
  <id_info>
    <org_study_id>ECP-EA</org_study_id>
    <nct_id>NCT03290274</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease</brief_title>
  <acronym>ECP-EA</acronym>
  <official_title>Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Carlos, Madrid</source>
  <oversight_info>
    <has_dmc>No</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>
      Approximately one million of Spaniards suffer from AlzhEimer´s Disease (AD) and this figure&#xD;
      is expected to triple by 20150. The approved treatments modulate neurotransmission in general&#xD;
      and are not specific or anatomically directed. In AD there is a dysfunction in cognitive and&#xD;
      memory circuits. It has been shown that the deep brain stimulation (DBS) can specially&#xD;
      modulate circuits in such a way that is modulable, and this approach is safe. The safety of&#xD;
      this treatment and its biological effects are convincing enough to require further study of&#xD;
      possible therapeutic effects of DBS in AD. The objectives are: To evaluate the security of&#xD;
      DBS in AD (main objective). To study the influence of DBS in the progress of AD, to compare&#xD;
      the effects of DBS on the brain metabolism neural connectivity and hubs using MEG, and to&#xD;
      compare the effects between two different groups: fornix and Basal nucleus of Meynert (BNM).&#xD;
      To achieve this, a prospective, double-blind comparison study between groups will be&#xD;
      conducted, to evaluate the effects of DBS in 6 patients: group I (fornix) and group II (&#xD;
      BNM).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Security</measure>
    <time_frame>2 years</time_frame>
    <description>Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Deep brain stimulation (fornix)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep brain stimulation at fornix area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep brain stimulation (Basal nucleus of Meynert)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep brain stimulation at Basal nucleus of Meynert</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep brain stimulation (fornix)</intervention_name>
    <description>Deep brain stimulation at fornix</description>
    <arm_group_label>Deep brain stimulation (fornix)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep brain stimulation (Basal nucleus of Meynert)</intervention_name>
    <description>Deep brain stimulation AT Basal nucleus of Meynert</description>
    <arm_group_label>Deep brain stimulation (Basal nucleus of Meynert)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: Between 50-80 years old&#xD;
&#xD;
          -  Diagnosis criteria of Alzheimer disease (Dubois criteria) in the previous 2 years&#xD;
&#xD;
          -  Presence of tau, p-tau or Aβ in cerebrospinal fluid or positive amiloid-PET scan&#xD;
&#xD;
          -  Clinical dementia rating scale (CDR): 1&#xD;
&#xD;
          -  Use of cholinesterase inhibitors and/or memantine during one year at least, and&#xD;
             worsening in neuropsychologic tests in spite of the treatment&#xD;
&#xD;
          -  Informed consent (patient and caregiver or legal representative)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain structural disorders: primary or metastatic tumor, Hydrocephalus, stroke, brain&#xD;
             abscess or cerebral malformation&#xD;
&#xD;
          -  Vascular dementia (NINCDS-AIREN criteria)&#xD;
&#xD;
          -  Neurodegenerative disease other than AD&#xD;
&#xD;
          -  Psychiatric disease&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Severe or unstable comorbidity (mellitus diabetes, high blood pressure…)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurora Viloria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinico San Carlos</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurora Viloria, MD</last_name>
    <phone>+34913003306</phone>
    <email>mariaaurora.viloria@salud.madrid.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurora Viloria, MD</last_name>
      <phone>+34913003306</phone>
      <email>mariaaurora.viloria@salud.madrid.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Juan Antonio Barcia Albacar</investigator_full_name>
    <investigator_title>Head of Neurosurgery Department</investigator_title>
  </responsible_party>
  <keyword>Deep brain stimulation</keyword>
  <keyword>Alzheimer´s Disease</keyword>
  <keyword>Fornix</keyword>
  <keyword>Basal nucleus of Meynert</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03290274
org study id: ECP-EA
nct id: NCT03290274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Approximately one million of Spaniards suffer from AlzhEimer´s Disease (AD) and this figure
      is expected to triple by 20150. The approved treatments modulate neurotransmission in general
      and are not specific or anatomically directed. In AD there is a dysfunction in cognitive and
      memory circuits. It has been shown that the deep brain stimulation (DBS) can specially
      modulate circuits in such a way that is modulable, and this approach is safe. The safety of
      this treatment and its biological effects are convincing enough to require further study of
      possible therapeutic effects of DBS in AD. The objectives are: To evaluate the security of
      DBS in AD (main objective). To study the influence of DBS in the progress of AD, to compare
      the effects of DBS on the brain metabolism neural connectivity and hubs using MEG, and to
      compare the effects between two different groups: fornix and Basal nucleus of Meynert (BNM).
      To achieve this, a prospective, double-blind comparison study between groups will be
      conducted, to evaluate the effects of DBS in 6 patients: group I (fornix) and group II (
      BNM).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Security
time frame: 2 years
description: Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis
arm group label: Deep brain stimulation (fornix)
arm group type: Experimental
description: Deep brain stimulation at fornix area
arm group label: Deep brain stimulation (Basal nucleus of Meynert)
arm group type: Experimental
description: Deep brain stimulation at Basal nucleus of Meynert
intervention type: Device
intervention name: Deep brain stimulation (fornix)
description: Deep brain stimulation at fornix
arm group label: Deep brain stimulation (fornix)
intervention type: Device
intervention name: Deep brain stimulation (Basal nucleus of Meynert)
description: Deep brain stimulation AT Basal nucleus of Meynert
arm group label: Deep brain stimulation (Basal nucleus of Meynert)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Aurora Viloria, MD
role: Principal Investigator
affiliation: Hospital Clinico San Carlos
last name: Aurora Viloria, MD
phone: +34913003306
email: mariaaurora.viloria@salud.madrid.org
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Juan Antonio Barcia Albacar
investigator title: Head of Neurosurgery Department
mesh term: Alzheimer Disease