<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/NCT04496778</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/0027772</org_study_id>
    <nct_id>NCT04496778</nct_id>
  </id_info>
  <brief_title>Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients</brief_title>
  <official_title>The Beneficial Effect of Low Level Laser Therapy Combined With Nasal Irradiation on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Alzheimer's is a type of dementia that affects memory, thinking and behavior. Symptoms&#xD;
      eventually grow severe enough to interfere with daily tasks. this study aimed to delay the&#xD;
      deterioration of anemic elderly condition as memory affection interfere with daily life&#xD;
      activities and social interaction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alzheimer's disease is the commonest cause of dementia and describes a clinical syndrome made&#xD;
      up of three domains. First, a neuro-psychological domain encompassing those deficits of&#xD;
      cognitive function such as amnesia (memory loss), aphasia (language disturbance), apraxia&#xD;
      (the inability to carry out motor tasks despite intact motor functions) and agnosia (the&#xD;
      inability to recognize people or objects despite intact sensory functions). Second, a group&#xD;
      of psychiatric symptoms and behavioral disturbances, which have been termed neuro-psychiatric&#xD;
      features, non-cognitive phenomena, or behavioral and psychological symptoms of dementia&#xD;
      Alzheimer's disease is substantially increased among people aged 65 years or more, with a&#xD;
      progressive decline in memory, thinking, language and learning capacity. Alzheimer's disease&#xD;
      should be differentiated from normal age-related decline in cognitive function, which is more&#xD;
      gradual and associated with less disability. Diabetes, hypertension, smoking, obesity, and&#xD;
      dyslipidemia have all been found to increase risk as well a history of brain trauma,&#xD;
      cerebrovascular disease, and vasculopathies.&#xD;
&#xD;
      Dementia affects approximately 5%-8% of individuals over age 65, 15%- 20% of individuals over&#xD;
      age 75, and 25%-50% of individuals over age 85. Alzheimer disease is the most common&#xD;
      dementia, accounting for 50%-75% of the total, with a greater proportion in the higher age&#xD;
      ranges Dementia is expensive. The financial costs of managing Alzheimer's disease are&#xD;
      enormous. The cost of illness is high in terms of both public and private resources. Families&#xD;
      and caregivers who are required to provide care and patients affected by dementia also pay a&#xD;
      high price in terms of their quality of life The primary goals of treatment are to maximize&#xD;
      the patient's ability to function in daily life, maintain quality of life, slow the&#xD;
      progression of symptoms, and treat depression or disruptive behaviors Low level laser therapy&#xD;
      is a safe, non-invasive, and non-thermal modality that is based on a strong body of research&#xD;
      dating back to the 1960.It involved in treating several conditions, the mechanisms of action&#xD;
      involve the stimulation of mitochondria by the absorption of photons in cytochrome c oxidase,&#xD;
      resulting in increased adenosine triphosphate production, reduced oxidative stress,&#xD;
      anti-inflammatory effects, and increased focal cerebral blood flow&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 28, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of cognitive function</measure>
    <time_frame>3 months</time_frame>
    <description>comparison of Montreal assessment scale scores before and after the intervention It range between 0 and 30. A score of 26 or over is considered to be normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of hemoglobin level</measure>
    <time_frame>3 months</time_frame>
    <description>comparison of hemoglobin level for those anemic elderly before and after the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of balance</measure>
    <time_frame>3 months</time_frame>
    <description>comparison of berg balance scale scores before and after the intervention. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>comparison of quality of life for Alzheimer disease scores before and after the intervention. It comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole) for a total score of 13-52 with higher scores indicating better quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes of body mass index</measure>
    <time_frame>3 months</time_frame>
    <description>comparison of body weight (kilogram) before and after the study in relation to height per meter square (weight and height will be combined to report BMI in kg/m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of waist hip ratio</measure>
    <time_frame>3 months</time_frame>
    <description>changes of waist hip ratio before and after the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Cognitive Impairment, Mild</condition>
  <arm_group>
    <arm_group_label>low level laser plus exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham laser plus exercise</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>low level laser therapy ( laser acupuncture combined with nasal laser irradiation)</intervention_name>
    <description>Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist.&#xD;
Nasal Probe with 2 laser beams - is applied to the nose cavity</description>
    <arm_group_label>low level laser plus exercise</arm_group_label>
    <arm_group_label>sham laser plus exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aerobic exercise</intervention_name>
    <description>3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve</description>
    <arm_group_label>low level laser plus exercise</arm_group_label>
    <arm_group_label>sham laser plus exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sixty elderly patients aged from 65-75 y&#xD;
&#xD;
          -  Body mass index (BMI) ranged from 30 to 34.9 kg/m2&#xD;
&#xD;
          -  Mild cognitive dysfunction (Montreal cognitive assessment scores from 19-25&#xD;
&#xD;
          -  Anemic&#xD;
&#xD;
          -  The time between their diagnoses and participation in the study ranged from 6 months&#xD;
             to 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe cognitive impairment&#xD;
&#xD;
          -  History of neurological disease ,stroke or Cardiovascular disease&#xD;
&#xD;
          -  History of nasal bleeding or fracture&#xD;
&#xD;
          -  Known photo-sensitivity disorder&#xD;
&#xD;
          -  Current active cancer or within one year of cancer treatment or remission&#xD;
&#xD;
          -  Serious mental health illness that in the opinion of the investigator would preclude&#xD;
             the subject from study participation&#xD;
&#xD;
          -  Active infection, wound or other external trauma to the target area to receive the&#xD;
             laser therapy&#xD;
&#xD;
          -  Participation in a clinical study or other type of research in the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebtesam Nabil, doctoral</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo</name>
      <address>
        <city>Giza</city>
        <state>Dokki</state>
        <zip>11432</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 23, 2020</last_update_submitted>
  <last_update_submitted_qc>August 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ebtesam Nabil</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>low level laser</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>after 2 years of study completion till 3 months after</ipd_time_frame>
    <ipd_access_criteria>students and scientific researchers will be allowed to access</ipd_access_criteria>
    <ipd_url>http://Scholar.cu.edu.eg/p_t</ipd_url>
  </patient_data>
  <!-- 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/NCT04496778
org study id: P.T.REC/012/0027772
nct id: NCT04496778
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Alzheimer's is a type of dementia that affects memory, thinking and behavior. Symptoms
      eventually grow severe enough to interfere with daily tasks. this study aimed to delay the
      deterioration of anemic elderly condition as memory affection interfere with daily life
      activities and social interaction
Alzheimer's disease is the commonest cause of dementia and describes a clinical syndrome made
      up of three domains. First, a neuro-psychological domain encompassing those deficits of
      cognitive function such as amnesia (memory loss), aphasia (language disturbance), apraxia
      (the inability to carry out motor tasks despite intact motor functions) and agnosia (the
      inability to recognize people or objects despite intact sensory functions). Second, a group
      of psychiatric symptoms and behavioral disturbances, which have been termed neuro-psychiatric
      features, non-cognitive phenomena, or behavioral and psychological symptoms of dementia
      Alzheimer's disease is substantially increased among people aged 65 years or more, with a
      progressive decline in memory, thinking, language and learning capacity. Alzheimer's disease
      should be differentiated from normal age-related decline in cognitive function, which is more
      gradual and associated with less disability. Diabetes, hypertension, smoking, obesity, and
      dyslipidemia have all been found to increase risk as well a history of brain trauma,
      cerebrovascular disease, and vasculopathies.

      Dementia affects approximately 5%-8% of individuals over age 65, 15%- 20% of individuals over
      age 75, and 25%-50% of individuals over age 85. Alzheimer disease is the most common
      dementia, accounting for 50%-75% of the total, with a greater proportion in the higher age
      ranges Dementia is expensive. The financial costs of managing Alzheimer's disease are
      enormous. The cost of illness is high in terms of both public and private resources. Families
      and caregivers who are required to provide care and patients affected by dementia also pay a
      high price in terms of their quality of life The primary goals of treatment are to maximize
      the patient's ability to function in daily life, maintain quality of life, slow the
      progression of symptoms, and treat depression or disruptive behaviors Low level laser therapy
      is a safe, non-invasive, and non-thermal modality that is based on a strong body of research
      dating back to the 1960.It involved in treating several conditions, the mechanisms of action
      involve the stimulation of mitochondria by the absorption of photons in cytochrome c oxidase,
      resulting in increased adenosine triphosphate production, reduced oxidative stress,
      anti-inflammatory effects, and increased focal cerebral blood flow
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change of cognitive function
time frame: 3 months
description: comparison of Montreal assessment scale scores before and after the intervention It range between 0 and 30. A score of 26 or over is considered to be normal.
measure: changes of hemoglobin level
time frame: 3 months
description: comparison of hemoglobin level for those anemic elderly before and after the intervention
measure: changes of balance
time frame: 3 months
description: comparison of berg balance scale scores before and after the intervention. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function
measure: changes of quality of life
time frame: 3 months
description: comparison of quality of life for Alzheimer disease scores before and after the intervention. It comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole) for a total score of 13-52 with higher scores indicating better quality of life
measure: changes of body mass index
time frame: 3 months
description: comparison of body weight (kilogram) before and after the study in relation to height per meter square (weight and height will be combined to report BMI in kg/m^2)
measure: changes of waist hip ratio
time frame: 3 months
description: changes of waist hip ratio before and after the study
arm group label: low level laser plus exercise
arm group type: Active Comparator
description: acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months
arm group label: sham laser plus exercise
arm group type: Placebo Comparator
description: placebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months
intervention type: Device
intervention name: low level laser therapy ( laser acupuncture combined with nasal laser irradiation)
description: Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist.
Nasal Probe with 2 laser beams - is applied to the nose cavity
arm group label: low level laser plus exercise
arm group label: sham laser plus exercise
intervention type: Other
intervention name: aerobic exercise
description: 3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve
arm group label: low level laser plus exercise
arm group label: sham laser plus exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ebtesam Nabil, doctoral
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ebtesam Nabil
investigator title: principal investigator
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: after 2 years of study completion till 3 months after
ipd access criteria: students and scientific researchers will be allowed to access
ipd url: http://Scholar.cu.edu.eg/p_t