Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment

Aristotle University Of Thessaloniki2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2017年12月17日最近更新: 2020年6月22日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Aristotle University Of Thessaloniki
入组人数: 100
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 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

详细描述

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.

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 age-adjusted 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

•Visual and auditory acuity inadequate for neuropsychological testing
•Enrollment in other trials or studies not compatible with MICOIL
•History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
•Use of forbidden medications (listed below)
•Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
•Excluded Medication:
•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).