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

NCT04435509 | Unknown

• 1 other identifier: 31c/17-05-17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment,; Intervention; Greek Mountain Tea

Outcome Measures

Primary Outcomes (15)

• Neuropsychological Assessment- Measurements to Assess General Cognitive Function

  Changes in Mini-Mental State Examination (MMSE) score

  baseline, 12 and 24 months

• FUCAS-Measurements to Assess Daily Functionality

  Changes in Functional cognitive assessment scale (FUCAS) score

  baseline, 12 and 24 months

• Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Letter \& Category Fluency Test

  baseline, 12 and 24 months

• CDR- Measurements to Assess General Cognitive Function

  Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)

  baseline, 12 and 24 months

• MoCA- Measurements to Assess General Cognitive Function

  Changes in Montreal Cognitive Assessment (MoCA)

  baseline, 12 and 24 months

• CANTAB- Measurements to Assess General Cognitive Function

  Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)

  baseline, 12 and 24 months

• Clock Drawing test- Measurements to Assess General Cognitive Function

  Changes in the Clock Drawing test

  baseline, 12 and 24 months

• Logical Memory test- Measurements to Assess General Cognitive Function

  Changes in the Logical Memory test

  baseline, 12 and 24 months

• Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function

  Changes in the Digit Span Forward \& Backward test

  baseline, 12 and 24 months

• WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function

  Changes in the WAIS-R Digit Symbol Substitution Test

  baseline, 12 and 24 months

• TMT part A and B- Measurements to Assess General Cognitive Function

  Changes in the Trail Making Test

  baseline, 12 and 24 months

• ADASCog-Measurements to Assess Daily Functionality

  Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)

  baseline, 12 and 24 months

• Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality

  Changes in Functional Rating Scale for Dementia (FRSSD)

  baseline, 12 and 24 months

• Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Auditory Verbal Learning Test

  baseline, 12 and 24 months

• Boston Naming Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Boston Naming Test

  baseline, 12 and 24 months

Secondary Outcomes (4)

• NeuroImaging

  baseline, 12 and 24 months]

• CSF - beta amyloid

  baseline, 12 and 24 months

• CSF TAU-protein

  baseline, 12 and 24 months

• Electroencephalography recording

  baseline, 12 and 24 months

Other Outcomes (2)

• Weight in Kilograms

  baseline, 12 and 24 months

• Height in Meters

  baseline, 12 and 24 months

Study Arms (2)

Greek Mountain Tea

EXPERIMENTAL

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

Mediterranean Diet

PLACEBO COMPARATOR

50 patients same dietary habits and a Mediterranean dietary protocol Intervention: Mediterranean diet.

Other: Mediterranean Diet

Interventions

1000+ Greek Mountain Tea DIETARY_SUPPLEMENT

Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams (4 grams 3 times per day ) 50 grams per month

Greek Mountain Tea

Mediterranean Diet OTHER

a Mediterranean dietary protocol

Mediterranean Diet

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Greek Alzheimer's Association and Related Disorders

Thessaloniki, Thessaloniki, 54248, Greece

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders

Model Details: Single (Participant)

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: June 17, 2020
• Study Start: November 17, 2019
• Primary Completion: September 30, 2020
• Study Completion: May 30, 2021
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)