<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/NCT04436614</url>
  </required_header>
  <id_info>
    <org_study_id>31b/17-05-17</org_study_id>
    <nct_id>NCT04436614</nct_id>
  </id_info>
  <brief_title>Management of Mild Cognitive Impairment Patients With Aloe and Crocus - BALSAM</brief_title>
  <acronym>BALSAM</acronym>
  <official_title>Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</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>
      There is accumulating evidence suggesting that Aloe vera and Crocus (saffron) may have a&#xD;
      positive impact on conditions involving cognitive deficits, such as Mild Cognitive Impairment&#xD;
      (MCI) and AD. More specifically, aloe vera gel contains powerful antioxidants, which belong&#xD;
      to a large family of substances known as polyphenols. Aloe has also been proven to possess&#xD;
      cholinergic and cognitive enhancing capabilities. Crocus is deeper studied and it shows&#xD;
      promising results in neuroprotection against AD through various suggested mechanisms, such as&#xD;
      the enhancement of amyloid-beta clearance in the brain and the inhibition of neurofibrillary&#xD;
      tangles formation. For this reason, it would be interesting to study the effects of&#xD;
      combination of Aloe Vera and Crocus . The aim of the study is to evaluate the beneficial&#xD;
      effect of Aloe Vera and Crocus (saffron) in comparison with Aloe (simple)on patients&#xD;
      diagnosed with mild cognitive impairment MCI.&#xD;
&#xD;
      Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel&#xD;
      Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES OF THE TRIAL&#xD;
&#xD;
      The objectives of this study are:&#xD;
&#xD;
      To investigate the efficacy of Aloe Vera and Crocus as a disease course modifying treatment&#xD;
      for MCI in a phase III double-blind placebo-controlled study.&#xD;
&#xD;
      To investigate the effects in objective measurements in patients with MCI.&#xD;
&#xD;
      STUDY DESIGN This is a Greek, randomised, double-blind, placebo-controlled study group of&#xD;
      compared Aloe Vera and Crocus with placebo. Qualifying patients will be randomly assigned to&#xD;
      receive 45 mL of Aloe Vera and Crocus or placebo (ALOE) or mediterranean dietary protocol on&#xD;
      a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7&#xD;
      days after beginning of the treatment.&#xD;
&#xD;
      Duration The total study duration will be 36 months. Patients will receive study medication&#xD;
      for 24 months.The recruitment will be about 6 months and the statistics and the preparation&#xD;
      of the paper other 6 months.&#xD;
&#xD;
      Number of Subjects One hundred fifty (150) subjects total will be enrolled. ; Fifty (50) in&#xD;
      the experimental group (Aloe Vera with Crocus); Fifty (50) in the Control Group 1(Aloe) and&#xD;
      fifty (50) in control Group 2(same dietary habits-mediterranean dietary protocol).&#xD;
&#xD;
      Patient Eligibility Screening Form (ESF)&#xD;
&#xD;
      An eligibility form documenting the patient's fulfilment of the entry criteria will be&#xD;
      completed by the assessor. The following information will be included in the ESF:&#xD;
&#xD;
      Patient identification: Initials (First initial of first name and First initial of surname),&#xD;
      date of birth and Patient Identification Number.&#xD;
&#xD;
      Eligibility Screening; Checklist of inclusion and exclusion criteria Eligibility Statement;&#xD;
      for patients found to be ineligible, the reason for ineligibility must be stated Written&#xD;
      informed consent will be obtained from the subject . The informed consent form must be&#xD;
      co-signed by the physician. The nature of the study and the potential risks associated with&#xD;
      the trial will be explained to all subject candidates and their responsible informants.&#xD;
&#xD;
      Signature and date: the ESF may be completed by an assessor but it is required that the&#xD;
      principal investigator/study clinician sign and date the ESF to verify eligibility of the&#xD;
      patient for inclusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2017</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</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>
    <intervention_model_description>Single (Participant)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single (Participant)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychological Assessment- Measurements to Assess General Cognitive Function.</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Mini-Mental State Examination (MMSE) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FUCAS-Measurements to Assess Daily Functionality</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Functional cognitive assessment scale (FUCAS) score score scale:0-42,cut offs:&lt;42</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter &amp; Category Fluency Test- Measurement to Assess Verbal Fluency and Learning</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Letter &amp; Category Fluency Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CDR- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MoCA- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Montreal Cognitive Assessment (MoCA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clock Drawing test- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Clock Drawing test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Logical Memory test- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Logical Memory test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Digit Span Forward &amp; Backward test- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Digit Span Forward &amp; Backward test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the WAIS-R Digit Symbol Substitution Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TMT part A and B- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Trail Making Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADASCog-Measurements to Assess Daily Functionality</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Functional Rating Scale for Dementia (FRSSD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Auditory Verbal Learning Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NeuroImaging</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSF - beta amyloid</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in mean values on high sensitivity beta-amyloid 1-42 protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSF TAU-protein</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in mean values on TAU-protein in cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electroencephalography recording</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) Electroencephalography recording Changes in Electroencephalography (EEG), resting state. The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight in Kilograms</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in weight</description>
  </other_outcome>
  <other_outcome>
    <measure>Height in Meters</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Height</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Aloe Vera and Crocus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 patients Aloe Vera and Crocus (saffron) 1L, 1 bottle per 15 days. Dietary Supplement: Aloe Vera and Crocus (saffron) in a glass bottle Intervention: Dietary Supplement: Aloe Vera and Crocus (saffron) in a glass bottle 1L, per 15 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aloe Vera</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>50 patients Aloe Vera (simple) in a glass bottle 1L, 1 bottle per 15 days. Dietary Supplement: Aloe Vera (simple) in a glass bottle Intervention: Dietary Supplement: Aloe Vera (simple) in a glass bottle in a glass bottle 1L, per 15 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mediterranean Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>50 patients Mediterranean dietary protocol Intervention:mediterranean diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Supplement:Aloe Vera with Crocus (saffron)</intervention_name>
    <description>Dietary Supplement:Aloe Vera with Crocus (saffron) with 1L of Aloe Vera with Crocus (saffron) 1 glass bottle per 15 days</description>
    <arm_group_label>Aloe Vera and Crocus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Supplement:Aloe Vera (simple)</intervention_name>
    <description>Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days</description>
    <arm_group_label>Aloe Vera</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Supplement:Mediterranean Diet</intervention_name>
    <description>Dietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet</description>
    <arm_group_label>Mediterranean Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Memory Complaints&#xD;
&#xD;
          -  Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the&#xD;
             Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory&#xD;
             Scale-R.&#xD;
&#xD;
          -  MMSE 24-30&#xD;
&#xD;
          -  CDR(sum of boxes) &gt;= 0,5&#xD;
&#xD;
          -  Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)&#xD;
&#xD;
          -  Geriatric Depression Scale (GDS) &lt;6&#xD;
&#xD;
          -  Hachinski Modified Ischemic scale &lt;= 4&#xD;
&#xD;
          -  Stability of Permitted Medications for 4 weeks&#xD;
&#xD;
          -  Years of education: &gt;= 5&#xD;
&#xD;
          -  Proficient language fluency&#xD;
&#xD;
          -  Compliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual and auditory acuity inadequate for neuropsychological testing&#xD;
&#xD;
          -  Enrollment in other trials or studies not compatible with MICOIL&#xD;
&#xD;
          -  History of significant neurological or psychiatric illnesses or presence of other&#xD;
             diseases precluding enrollment.&#xD;
&#xD;
          -  Use of forbidden medications (listed below)&#xD;
&#xD;
          -  Ferromagnetic implants and devices (including implants or devices held in place by&#xD;
             sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not&#xD;
             eligible for MRI scanning. Brain malformation or other conditions that may complicate&#xD;
             lumbar puncture&#xD;
&#xD;
        Excluded Medication:&#xD;
&#xD;
          -  Antidepressants with anti-cholinergic properties.&#xD;
&#xD;
          -  Regular use of narcotic analgesics (&gt;2 doses per week) within 4 weeks of screening.&#xD;
&#xD;
          -  Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine,&#xD;
             thioridazine) within 4 weeks of screening.&#xD;
&#xD;
          -  Chronic use of other medications with significant central nervous system&#xD;
             anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).&#xD;
&#xD;
          -  Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine,&#xD;
             pergolide, selegeline) within 4 weeks of screening.&#xD;
&#xD;
          -  Participation in any other investigational drug study within 4 weeks of screening&#xD;
             (individuals may not participate in any drug study while participating in this&#xD;
             protocol).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Greek Alzheimer's Association and Related Disorders</name>
      <address>
        <city>Thessaloníki</city>
        <state>Thessaloniki</state>
        <zip>54248</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Tzekaki EE, Tsolaki M, Pantazaki AA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. Administration of the extra virgin olive oil (EVOO) in mild cognitive impairment (MCI) patients as a therapy for preventing the progress to AD. Hell J Nucl Med. 2019 Sep-Dec;22 Suppl 2:181.</citation>
    <PMID>31802059</PMID>
  </reference>
  <results_reference>
    <citation>Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.</citation>
    <PMID>27472878</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 24, 2019</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Magda Tsolaki</investigator_full_name>
    <investigator_title>MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders</investigator_title>
  </responsible_party>
  <keyword>Mild Cognitive Impairment,</keyword>
  <keyword>Aloe,</keyword>
  <keyword>Crocus,</keyword>
  <keyword>Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04436614
org study id: 31b/17-05-17
nct id: NCT04436614
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is accumulating evidence suggesting that Aloe vera and Crocus (saffron) may have a
      positive impact on conditions involving cognitive deficits, such as Mild Cognitive Impairment
      (MCI) and AD. More specifically, aloe vera gel contains powerful antioxidants, which belong
      to a large family of substances known as polyphenols. Aloe has also been proven to possess
      cholinergic and cognitive enhancing capabilities. Crocus is deeper studied and it shows
      promising results in neuroprotection against AD through various suggested mechanisms, such as
      the enhancement of amyloid-beta clearance in the brain and the inhibition of neurofibrillary
      tangles formation. For this reason, it would be interesting to study the effects of
      combination of Aloe Vera and Crocus . The aim of the study is to evaluate the beneficial
      effect of Aloe Vera and Crocus (saffron) in comparison with Aloe (simple)on patients
      diagnosed with mild cognitive impairment MCI.

      Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel
      Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
OBJECTIVES OF THE TRIAL

      The objectives of this study are:

      To investigate the efficacy of Aloe Vera and Crocus as a disease course modifying treatment
      for MCI in a phase III double-blind placebo-controlled study.

      To investigate the effects in objective measurements in patients with MCI.

      STUDY DESIGN This is a Greek, randomised, double-blind, placebo-controlled study group of
      compared Aloe Vera and Crocus with placebo. Qualifying patients will be randomly assigned to
      receive 45 mL of Aloe Vera and Crocus or placebo (ALOE) or mediterranean dietary protocol on
      a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7
      days after beginning of the treatment.

      Duration The total study duration will be 36 months. Patients will receive study medication
      for 24 months.The recruitment will be about 6 months and the statistics and the preparation
      of the paper other 6 months.

      Number of Subjects One hundred fifty (150) subjects total will be enrolled. ; Fifty (50) in
      the experimental group (Aloe Vera with Crocus); Fifty (50) in the Control Group 1(Aloe) and
      fifty (50) in control Group 2(same dietary habits-mediterranean dietary protocol).

      Patient Eligibility Screening Form (ESF)

      An eligibility form documenting the patient's fulfilment of the entry criteria will be
      completed by the assessor. The following information will be included in the ESF:

      Patient identification: Initials (First initial of first name and First initial of surname),
      date of birth and Patient Identification Number.

      Eligibility Screening; Checklist of inclusion and exclusion criteria Eligibility Statement;
      for patients found to be ineligible, the reason for ineligibility must be stated Written
      informed consent will be obtained from the subject . The informed consent form must be
      co-signed by the physician. The nature of the study and the potential risks associated with
      the trial will be explained to all subject candidates and their responsible informants.

      Signature and date: the ESF may be completed by an assessor but it is required that the
      principal investigator/study clinician sign and date the ESF to verify eligibility of the
      patient for inclusion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single (Participant)
primary purpose: Treatment
masking: Single (Participant)
masking description: Single (Participant)
measure: Neuropsychological Assessment- Measurements to Assess General Cognitive Function.
time frame: baseline, 12 and 24 months
description: Changes in Mini-Mental State Examination (MMSE) score
measure: FUCAS-Measurements to Assess Daily Functionality
time frame: baseline, 12 and 24 months
description: Changes in Functional cognitive assessment scale (FUCAS) score score scale:0-42,cut offs:<42
measure: Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
time frame: baseline, 12 and 24 months
description: Changes in the Letter & Category Fluency Test
measure: CDR- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
measure: MoCA- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in Montreal Cognitive Assessment (MoCA)
measure: Clock Drawing test- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Clock Drawing test
measure: Logical Memory test- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Logical Memory test
measure: Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Digit Span Forward & Backward test
measure: WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the WAIS-R Digit Symbol Substitution Test
measure: TMT part A and B- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Trail Making Test
measure: ADASCog-Measurements to Assess Daily Functionality
time frame: baseline, 12 and 24 months
description: Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
measure: Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
time frame: baseline, 12 and 24 months
description: Changes in Functional Rating Scale for Dementia (FRSSD)
measure: Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
time frame: baseline, 12 and 24 months
description: Changes in the Auditory Verbal Learning Test
measure: NeuroImaging
time frame: baseline, 12 and 24 months
description: Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
measure: CSF - beta amyloid
time frame: baseline, 12 and 24 months
description: Changes in mean values on high sensitivity beta-amyloid 1-42 protein
measure: CSF TAU-protein
time frame: baseline, 12 and 24 months
description: Changes in mean values on TAU-protein in cerebrospinal fluid
measure: Electroencephalography recording
time frame: baseline, 12 and 24 months
description: Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) Electroencephalography recording Changes in Electroencephalography (EEG), resting state. The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position
measure: Weight in Kilograms
time frame: baseline, 12 and 24 months
description: Changes in weight
measure: Height in Meters
time frame: baseline, 12 and 24 months
description: Changes in Height
arm group label: Aloe Vera and Crocus
arm group type: Experimental
description: 50 patients Aloe Vera and Crocus (saffron) 1L, 1 bottle per 15 days. Dietary Supplement: Aloe Vera and Crocus (saffron) in a glass bottle Intervention: Dietary Supplement: Aloe Vera and Crocus (saffron) in a glass bottle 1L, per 15 days.
arm group label: Aloe Vera
arm group type: Placebo Comparator
description: 50 patients Aloe Vera (simple) in a glass bottle 1L, 1 bottle per 15 days. Dietary Supplement: Aloe Vera (simple) in a glass bottle Intervention: Dietary Supplement: Aloe Vera (simple) in a glass bottle in a glass bottle 1L, per 15 days.
arm group label: Mediterranean Diet
arm group type: Other
description: 50 patients Mediterranean dietary protocol Intervention:mediterranean diet
intervention type: Dietary Supplement
intervention name: Dietary Supplement:Aloe Vera with Crocus (saffron)
description: Dietary Supplement:Aloe Vera with Crocus (saffron) with 1L of Aloe Vera with Crocus (saffron) 1 glass bottle per 15 days
arm group label: Aloe Vera and Crocus
intervention type: Dietary Supplement
intervention name: Dietary Supplement:Aloe Vera (simple)
description: Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days
arm group label: Aloe Vera
intervention type: Dietary Supplement
intervention name: Dietary Supplement:Mediterranean Diet
description: Dietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet
arm group label: Mediterranean Diet
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Greece
citation: Tzekaki EE, Tsolaki M, Pantazaki AA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. Administration of the extra virgin olive oil (EVOO) in mild cognitive impairment (MCI) patients as a therapy for preventing the progress to AD. Hell J Nucl Med. 2019 Sep-Dec;22 Suppl 2:181.
PMID: 31802059
citation: Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.
PMID: 27472878
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Magda Tsolaki
investigator title: MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No