Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Greek Mountain Tea Patiens With Mild Cognitive Impairment

Aristotle University Of Thessaloniki2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2019年11月17日最近更新: 2020年6月17日

适应症

试验速览

阶段: 不适用
发起方: Aristotle University Of Thessaloniki
入组人数: 50
试验地点: 2
主要终点: Neuropsychological Assessment- Measurements to Assess General Cognitive Function

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

盲法说明

Single (Participant)

入排标准

年龄范围: 55 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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).