CTRI/2019/08/020711已完成不适用
A Prospective, Open label, multi-center Clinical Study to evaluate the efficacy and safety of Neuralzhein in management of Mild to Moderate age onset Dementia.
Lexxus Laboratories DBA OPUS PHARMA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Change in the scores of ACE (R) from baseline to last visit.
研究概览
简要总结
Thestudy is indicated for the management of symptoms in patients with age-onsetdementia induced disease progression involving Mixed Dementia impairingcognitive traits like Memory loss, short term & long term loss, visualperception & auditory recognition capacity, mood swing, speech impairment,reading and learning inability, sleep cycle changes, irritability,inattentiveness and difficulty in focusing, spatial arrangement recall skilland reduced eye movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 55.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject should be able to give written consent for participation on their own or through their legally acceptable representative/Caregiver.
- •2.Adult males or females aged between 55 years to 75 years with the diagnosis of any type of age onset Mixed Dementia Insulin resistance associated Diabetes Mellitus, Thyroid disorders, Vitamin B12 deficiency, Vitamin D deficiency.
- •3.Subjects with following conditions will be recruited: 4.Memory impairment (short term and long term), particularly recent events.
- •5.Spatial arrangement recalls skills
- •Mood swings 7.Irritability, Inattentiveness, difficulty in focusing and apathy 8.Speech impairment
- •Reading and learning inability
- •Sleep cycle changes 11.Personality changes 12.Inability to perform daily activities
- •Disorientation and reduced eye movement.
- •Visual perception & auditory recognition capacity.
- •Subjects with Mini-Mental State Examination (MMSE) score of 13 to 24
- •Subjects with Modified Hachinski Ischemic Scale (MHIS) score of ¬¬¬¬ 4 or less.
- •The subjects having an identified, reliable, study partner (care giver) who is able to read, write and understand the study procedures and can attend study appointments.
- •The caregiver should have the ability to answer questions about the subject’s behavior, activity of daily living, quality of life, and their own level of stress.
- •The compliance card has to be filled by the caregiver.
- •Subjects newly diagnosed with dementia who are willing to participate into the study, subjects who have not shown any improvement with other medications or subjects who are ready to quit the ongoing treatment and ready to start IP.
- •Subjects must have gradual and progressive change in memory function for >6 months.
- •Subjects who are willing to undergo MRI if required.
- •Subjects should have adequate visual and auditory acuity to allow neuropsychological testing.
- •22.Subjects who will be able to travel to the research site without being non-compliant with the visits and procedures.
排除标准
- •Presence of non-neurological medical conditions interfering with cognition.
- •Subject having any contraindications or inability to tolerate brain magnetic resonance imaging (MRI) and Positron emission tomography (PET scans)
- •Subject with history of myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.
- •Subject having history of seizures.
- •Subjects having significant neurological disease affecting the nervous system, other than dementia, that affects cognition or may affect completion of the study.
- •Subjects having history of cancer within the last 5 years
- •Subjects having serious risk for suicide.
- •Subjects having history of drug or alcohol use disorder within the last 2 years.
- •Subjects mustn’t be immunocompromised, or have Hepatitis B or C.
- •Clinically significant uncontrolled medical or psychiatric illness Renal or liver impairment.
- •Terminal illness (i.e., life expectancy < 1 year)
- •Participation in another research study that could potentially confound current study (e.g., medication or behavioral intervention)
- •History of head trauma associated with injury-onset cognitive complaints or loss of consciousness for 10 minutes or longer.
- •Women with Child bearing capabilities.
- •Subjects taking sedative, antidepressants or antipsychotics
- •Any surgical procedure in the recent time.
- •Any autoimmune disorders.
- •Febrile patients.
结局指标
主要结局
1. Change in the scores of ACE (R) from baseline to last visit.
时间窗: 3 months
2. Change in the scores of MHIS from baseline to last visit.
时间窗: 3 months
次要结局
- 1. To know the occurrence of the safety part in case of Adverse Drug Reactions,Adverse Events or Serious Adverse Events.(2. To measure the quality of life of patients with the help of QOL questionnaire from the baseline till the last visit.)
研究者
研究点 (1)
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