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Management of Mild Cognitive Impairment Patients With Greek Mountain Tea - TEAMENTIA (TEAMENTIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435509
Recruitment Status : Active, not recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Magda Tsolaki, Aristotle University Of Thessaloniki

Brief Summary:

There is accumulating evidence suggesting that Greek Mountain Tea may have a positive impact on conditions involving cognitive deficits, such as Mild Cognitive Impairment (MCI) and AD. More specifically, greek mountain olympos tee is rich in essential oils, flavonoids, diterpenes and phenylpropanes, which are primarily responsible for its pharmacological properties. Its confirmed antioxidant properties are what make mountain tea promising against Alzheimer's disease and other neurodegenerative diseases. It has also been proven to possess cholinergic and cognitive enhancing capabilities. Greek Mountain Tea 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. The aim of the study is to evaluate the beneficial effect of Greek Mountain Tea in 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


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dietary Supplement: 1000+ Greek Mountain Tea Other: Mediterranean Diet Not Applicable

Detailed Description:

OBJECTIVES OF THE TRIAL

The objectives of this study are:

To investigate the efficacy of Greek Mountain Tea 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 Greek Mountain Tea placebo. Qualifying patients will be randomly assigned to receive 12 grams of Greek Mountain Tea 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 (100) subjects total will be enrolled. ; Fifty (50) in the experimental group (Greek Mountain Tea); 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single (Participant)
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Greek Mountain Tea Patiens With Mild Cognitive Impairment
Actual Study Start Date : November 17, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Greek Mountain Tea
50 patients Greek Mountain Tea 50 grams one per 30 days. Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams Intervention:Greek Mountain Tea in a plastic bag.
Dietary Supplement: 1000+ Greek Mountain Tea
Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams (4 grams 3 times per day ) 50 grams per month

Placebo Comparator: Mediterranean Diet
50 patients same dietary habits and a Mediterranean dietary protocol Intervention: Mediterranean diet.
Other: Mediterranean Diet
a Mediterranean dietary protocol




Primary Outcome Measures :
  1. Neuropsychological Assessment- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Mini-Mental State Examination (MMSE) score

  2. FUCAS-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Functional cognitive assessment scale (FUCAS) score

  3. Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Letter & Category Fluency Test

  4. CDR- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)

  5. MoCA- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Montreal Cognitive Assessment (MoCA)

  6. CANTAB- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)

  7. Clock Drawing test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Clock Drawing test

  8. Logical Memory test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Logical Memory test

  9. Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Digit Span Forward & Backward test

  10. WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the WAIS-R Digit Symbol Substitution Test

  11. TMT part A and B- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Trail Making Test

  12. ADASCog-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)

  13. Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Functional Rating Scale for Dementia (FRSSD)

  14. Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Auditory Verbal Learning Test

  15. Boston Naming Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Boston Naming Test


Secondary Outcome Measures :
  1. NeuroImaging [ Time Frame: baseline, 12 and 24 months] ]
    Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)

  2. CSF - beta amyloid [ Time Frame: baseline, 12 and 24 months ]
    Changes in mean values on high sensitivity beta-amyloid 1-42 protein

  3. CSF TAU-protein [ Time Frame: baseline, 12 and 24 months ]
    Changes in mean values on TAU-protein in cerebrospinal fluid

  4. Electroencephalography recording [ Time Frame: baseline, 12 and 24 months ]
    • 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


Other Outcome Measures:
  1. Weight in Kilograms [ Time Frame: baseline, 12 and 24 months ]
    Changes in weight

  2. Height in Meters [ Time Frame: baseline, 12 and 24 months ]
    Changes in Height



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Memory Complaints
  • Abnormal memory function documented by scoring 1 SD below the ageadjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
  • MMSE 24-30
  • CDR(sum of boxes) >= 0,5
  • Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)
  • Geriatric Depression Scale (GDS) <6
  • Hachinski Modified Ischemic scale <= 4
  • Stability of Permitted Medications for 4 weeks
  • Years of education: >= 5
  • Proficient language fluency
  • Compliance

    -Exclusion Criteria:

  • Antidepressants with anti-cholinergic properties.
  • Regular use of narcotic analgesics (>2 doses per week) within 4 weeks of screening.
  • Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.
  • Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).
  • Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.
  • Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435509


Locations
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Greece
Greek Alzheimer's Association and Related Disorders
Thessaloníki, Thessaloniki, Greece, 54248
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Publications of Results:
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Responsible Party: Magda Tsolaki, MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04435509    
Other Study ID Numbers: 31c/17-05-17
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magda Tsolaki, Aristotle University Of Thessaloniki:
Mild Cognitive Impairment,
Intervention
Greek Mountain Tea
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders