Management of Mild Cognitive Impairment Patients With Greek Mountain Tea - TEAMENTIA
- Conditions
- Mild Cognitive Impairment
- Interventions
- Other: Mediterranean DietDietary Supplement: 1000+ Greek Mountain Tea
- Registration Number
- NCT04435509
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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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.
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MMSE 24-30
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CDR(sum of boxes) >= 0,5
-
Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)
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Geriatric Depression Scale (GDS) <6
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Hachinski Modified Ischemic scale <= 4
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Stability of Permitted Medications for 4 weeks
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Years of education: >= 5
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Proficient language fluency
-
Compliance
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediterranean Diet Mediterranean Diet 50 patients same dietary habits and a Mediterranean dietary protocol Intervention: Mediterranean diet. Greek Mountain Tea 1000+ 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.
- Primary Outcome Measures
Name Time Method Neuropsychological Assessment- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in Mini-Mental State Examination (MMSE) score
Clock Drawing test- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in the Clock Drawing test
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in the Digit Span Forward \& Backward test
TMT part A and B- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in the Trail Making Test
Boston Naming Test- Measurement to Assess Verbal Fluency and Learning baseline, 12 and 24 months Changes in the Boston Naming Test
CANTAB- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
FUCAS-Measurements to Assess Daily Functionality baseline, 12 and 24 months Changes in Functional cognitive assessment scale (FUCAS) score
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning baseline, 12 and 24 months Changes in the Letter \& Category Fluency Test
MoCA- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in Montreal Cognitive Assessment (MoCA)
ADASCog-Measurements to Assess Daily Functionality baseline, 12 and 24 months Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality baseline, 12 and 24 months Changes in Functional Rating Scale for Dementia (FRSSD)
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning baseline, 12 and 24 months Changes in the Auditory Verbal Learning Test
CDR- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
Logical Memory test- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in the Logical Memory test
WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function baseline, 12 and 24 months Changes in the WAIS-R Digit Symbol Substitution Test
- Secondary Outcome Measures
Name Time Method NeuroImaging baseline, 12 and 24 months] Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
CSF - beta amyloid baseline, 12 and 24 months Changes in mean values on high sensitivity beta-amyloid 1-42 protein
CSF TAU-protein baseline, 12 and 24 months Changes in mean values on TAU-protein in cerebrospinal fluid
Electroencephalography recording 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
Trial Locations
- Locations (1)
Greek Alzheimer's Association and Related Disorders
🇬🇷Thessaloníki, Thessaloniki, Greece