<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/NCT03255720</url>
  </required_header>
  <id_info>
    <org_study_id>diffusion tensor imaging</org_study_id>
    <nct_id>NCT03255720</nct_id>
  </id_info>
  <brief_title>Application of Diffusion Tensor Imaging in Alzheimer's Disease :Quantification of White Matter Micro-structural Changes</brief_title>
  <official_title>Application of Diffusion Tensor Imaging in Alzheimer's Disease:Quantification of White Matter Micro-structural Changes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Diffusion Tensor imaging of white matter degeneration in Alzheimer disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alzheimer's disease (AD) is the most common cause of dementia in the elderly, accountings for&#xD;
      60-70% of all demented cases. It is a neuro-pathological diagnosis determined by presence of&#xD;
      neurofibrillary tangles and senile plaques in the brain of patients with dementia. The&#xD;
      disease frequently starts with memory impairment, but is invariably followed by a progressive&#xD;
      global cognitive impairment. The major risk factor for Alzheimer disease is age, with&#xD;
      prevalence doubling every 5 years after the age of 65.&#xD;
&#xD;
      Diagnosis of Alzheimer's typically involves physical and neurological exams, as medical&#xD;
      history and mental status evaluation, laboratory investigations and it involves brain imaging&#xD;
      (such as MRI) which could identify other causes of problems such as stroke, tumor or head&#xD;
      trauma. By physical and neurological examination, Alzheimer's disease characterized by&#xD;
      gradual onset and progressive decline in cognition with sparring of motor and sensory&#xD;
      function until later stages; the average course of Alzheimer's disease is approximately a&#xD;
      decade, with a range of 3 to 20 years duration from diagnosis to death .Memory impairment is&#xD;
      present in the earliest stages of the disease; patients have difficulty learning new&#xD;
      information and retaining it for more than few minutes. As the disease advances, the ability&#xD;
      to learn increasingly compromised, more distant memories are lost. Other cognitive loses&#xD;
      include aphasia, apraxia, disorientation and impaired judgment. Cognitive impairment affects&#xD;
      daily life; patients have difficulty planning meals, managing finances or medication, using&#xD;
      telephone, driving. Many capacities may remain intact until later stages including&#xD;
      performance of self-care activities of daily living as eating, bathing. Patients evidence&#xD;
      personality alteration, irritability, anxiety, depression. Delusion, hallucination and&#xD;
      aggression. Laboratory Evaluation includes Biochemical markers as measurement of&#xD;
      Cerebrospinal fluid including Tau protein, amyloid beta peptides or neural thread protein and&#xD;
      measurement of urinary biomarkers including neural thread protein. Also testing including Apo&#xD;
      lipoprotein E epsilon 4 allele presenilin genes, amyloid precursor gene or TREM2. Diffusion&#xD;
      tensor imaging (DTI) is an imaging technology based on magnetic resonance diffusion weighted&#xD;
      imaging, which can make quantitative analysis of anisotropy of water molecules in different&#xD;
      directions, so as to observe the microstructure of tissues non-invasively. So Diffusion&#xD;
      tensor imaging can provide information of fiber orientation, the injury of fiber, and&#xD;
      membrane permeability which cannot be obtained from conventional MRI. Diffusion tensor&#xD;
      imaging enables mapping of White matter microstructure changes in development, aging and&#xD;
      neurological disorders, From the tensor, it's possible to derive the mean diffusivity (DM)&#xD;
      and the fractional anisotropy (FA) which is the most robust measures of anisotropy which&#xD;
      measure the degree of deviation from isotropic diffusion. ). More recently, an additional&#xD;
      DT-MRI derived index has been proposed .This index measures the degree of similarity of&#xD;
      orientation of neighboring voxels and its named inter-voxel coherence (C).&#xD;
&#xD;
      So Diffusion tensor imaging has therefore become a powerful technique in the study of&#xD;
      neurodegenerative diseases in recent years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Years</target_duration>
  <primary_outcome>
    <measure>the extent of tissue damage of several brain white matter regions in patients with Alzheimer's disease.</measure>
    <time_frame>4 years</time_frame>
    <description>provide a complete picture of the distribution of microstructural white matter damage in Alzheimer's disease</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Alzheimer Dementia</condition>
  <arm_group>
    <arm_group_label>20 patients with Alzheimer disease</arm_group_label>
    <description>The study will be performed at the Radiodiagnosis department of assiut university hospital.&#xD;
Selection of 20 patients clinically and laboratory diagnosed as Alzheimer disease and another 20 people matched healthy controls who have no complaints of cognitive problems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 people matched healthy controls</arm_group_label>
    <description>health control people who have no complaints of cognitive problems.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        old aged people over 60 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. cognitive complaints with interference in complex occupational and social activities.&#xD;
&#xD;
          2. changes in cognition reported by the patient ,informant or clinician.&#xD;
&#xD;
          3. absence of profound sub-cortical ischemic changes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. state of delirium&#xD;
&#xD;
          2. stroke event within 2 weeks&#xD;
&#xD;
          3. appearance of cortical and /cortico-subcortical non -lacunar territorial infarcts and&#xD;
             watershed infarcts ,hemorrhage ,signs of normal pressure hydrocephalus ,and specific&#xD;
             causes of white matter lesions (e.g. multiple sclerosis, sarcoidosis, brain&#xD;
             irradiation)&#xD;
&#xD;
          4. derangements in serology tests contributing to cognitive impairment (e.g. abnormal&#xD;
             levels of free T4 or rapid plasma reagin.&#xD;
&#xD;
          5. severe hearing or visual impairment.&#xD;
&#xD;
          6. cases of severe dementia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 23, 2017</last_update_submitted>
  <last_update_submitted_qc>September 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>shereen magdy</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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>August 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03255720/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03255720
org study id: diffusion tensor imaging
nct id: NCT03255720
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Diffusion Tensor imaging of white matter degeneration in Alzheimer disease
Alzheimer's disease (AD) is the most common cause of dementia in the elderly, accountings for
      60-70% of all demented cases. It is a neuro-pathological diagnosis determined by presence of
      neurofibrillary tangles and senile plaques in the brain of patients with dementia. The
      disease frequently starts with memory impairment, but is invariably followed by a progressive
      global cognitive impairment. The major risk factor for Alzheimer disease is age, with
      prevalence doubling every 5 years after the age of 65.

      Diagnosis of Alzheimer's typically involves physical and neurological exams, as medical
      history and mental status evaluation, laboratory investigations and it involves brain imaging
      (such as MRI) which could identify other causes of problems such as stroke, tumor or head
      trauma. By physical and neurological examination, Alzheimer's disease characterized by
      gradual onset and progressive decline in cognition with sparring of motor and sensory
      function until later stages; the average course of Alzheimer's disease is approximately a
      decade, with a range of 3 to 20 years duration from diagnosis to death .Memory impairment is
      present in the earliest stages of the disease; patients have difficulty learning new
      information and retaining it for more than few minutes. As the disease advances, the ability
      to learn increasingly compromised, more distant memories are lost. Other cognitive loses
      include aphasia, apraxia, disorientation and impaired judgment. Cognitive impairment affects
      daily life; patients have difficulty planning meals, managing finances or medication, using
      telephone, driving. Many capacities may remain intact until later stages including
      performance of self-care activities of daily living as eating, bathing. Patients evidence
      personality alteration, irritability, anxiety, depression. Delusion, hallucination and
      aggression. Laboratory Evaluation includes Biochemical markers as measurement of
      Cerebrospinal fluid including Tau protein, amyloid beta peptides or neural thread protein and
      measurement of urinary biomarkers including neural thread protein. Also testing including Apo
      lipoprotein E epsilon 4 allele presenilin genes, amyloid precursor gene or TREM2. Diffusion
      tensor imaging (DTI) is an imaging technology based on magnetic resonance diffusion weighted
      imaging, which can make quantitative analysis of anisotropy of water molecules in different
      directions, so as to observe the microstructure of tissues non-invasively. So Diffusion
      tensor imaging can provide information of fiber orientation, the injury of fiber, and
      membrane permeability which cannot be obtained from conventional MRI. Diffusion tensor
      imaging enables mapping of White matter microstructure changes in development, aging and
      neurological disorders, From the tensor, it's possible to derive the mean diffusivity (DM)
      and the fractional anisotropy (FA) which is the most robust measures of anisotropy which
      measure the degree of deviation from isotropic diffusion. ). More recently, an additional
      DT-MRI derived index has been proposed .This index measures the degree of similarity of
      orientation of neighboring voxels and its named inter-voxel coherence (C).

      So Diffusion tensor imaging has therefore become a powerful technique in the study of
      neurodegenerative diseases in recent years.
observational model: Case-Control
time perspective: Prospective
measure: the extent of tissue damage of several brain white matter regions in patients with Alzheimer's disease.
time frame: 4 years
description: provide a complete picture of the distribution of microstructural white matter damage in Alzheimer's disease
arm group label: 20 patients with Alzheimer disease
description: The study will be performed at the Radiodiagnosis department of assiut university hospital.
Selection of 20 patients clinically and laboratory diagnosed as Alzheimer disease and another 20 people matched healthy controls who have no complaints of cognitive problems.
arm group label: 20 people matched healthy controls
description: health control people who have no complaints of cognitive problems.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: shereen magdy
investigator title: principal investigator
mesh term: Alzheimer Disease
sharing ipd: No
provided document: 