CTRI/2018/11/016278已完成未知
A Randomized, Blinded, Prospective, Placebo Controlled, Investigator Initiated Study to Evaluate Efficacy and Safety of Dexmedetomidine Injection in the agitated subjects with Mild Probable Alzheimerâ??s Disease - Alzheimer IIT
Dr Hrishikesh Kumar0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Male and female subjects with 55 to 75 years (both inclusive) of age.
- •2.Known cases of Mild Probable Alzheimerâ??s disease in accordance with NINCDS/ADRDA Criteria for Diagnosis of Alzheimerâ??s Disease with a Mini-Mental State Score between 18 â?? 23.
- •3.Subjects with RASS score of +1 or +2 on the Day -1 and prior to IP administration on Day 1.
- •4.In the opinion of the principal investigator or designee, sufficiently physically healthy to receive an IV dose of dexmedetomidine sufficient to cause drowsiness temporarily arousable by verbal stimulation.
- •5.Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening.
- •6.CT or MRI scan performed within the past 12 months or at screening that showed no evidence of tumour, other structural abnormality or degenerative disease other than Alzheimerâ??s disease.
- •7.Neurological examination without focal changes (excluding changes attributed to peripheral trauma).
- •8.Subject had provided full informed consent prior to performance of any protocol specified procedure or if unable to provide informed consent due to cognitive status, full informed consent on behalf of the subject was provided by a legally acceptable representative.
- •9.Agree to comply with the visit schedule and other requirements of the study.
- •10.Women must be postmenopausal as confirmed by FSH testing (serum FSH levels > 40 mIU/mL) during screening.
排除标准
- •1.History of allergic responses to Dexmedetomidine or other related drugs and any of its formulation ingredients.
- •2.Subjects treated with benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotics for agitation within 24 hours prior to study drug administration.
- •3.Subjects on Cholinesterase inhibitor for less than 1 month and not on a stable dose.
- •4.Focal neurological deficits, history of significant traumatic brain injury.
- •5.Subjects with clinically significant blood pressure values.
- •6.Presence of clinically significant psychiatric illnesses or unstable medical illnesses.
- •7.Clinically significant sleep apnea or chronic obstructive pulmonary disease.
- •8.Presence of any of the following cardiovascular comorbidities: advanced heart block (second-degree or above atrioventricular block without pacemaker), diagnosis of Sick Sinus Syndrome, History of severe ventricular dysfunction, Hypovolemia, Insulin dependent diabetes mellitus, Chronic hypertension not adequately controlled by antihypertensive medications.
- •9.History of syncope or other syncopal attacks, current evidence of orthostatic hypotension, Have a resting heart rate of < 60 beats per minutes or systolic blood pressure <110 mmHg or >140 mmHg or diastolic BP <70 mmHg or Ë? 95 mmHg.
- •10.Presence of Moderate â?? severe hepatic impairment (Pugh-Childs score > 7).
- •11.History or evidence of moderate to severe congestive heart failure defined by the New York Heart Association (class II-IV).
- •12.History or evidence of any other CNS disorder that could be interpreted as a cause of dementia e.g. cerebrovascular disease (stroke, transient ischemic attack, haemorrhage), structural abnormality, epilepsy, infectious or inflammatory / demyelinating CNS conditions, Parkinsonâ??s disease.
- •13.Subjects with vascular dementia as per the investigatorâ??s judgment.
- •14.Significant peripheral edema at the time of screening.
- •15.SBP > 165 mmHg or DBP > 95 mmHg while receiving optimal anti-hypertensive therapy according to local practice.
- •16.Subjects with clinically significant anaemia (i.e., Hb < 10 g/dL).
- •17.Subjects with HbA1c > 8%.
- •18.Positive urine drug screen for drugs of abuse with the exception that participants testing positive for benzodiazepines may participate based on the investigatorâ??s discretion based on the assessment of the patientsâ?? presenting clinical status.
- •19.A positive test result for HIV antibody.
- •20.A positive hepatitis screen (includes subtypes B & C).
- •21.Significant risk of suicide or homicide in the investigatorâ??s opinion.
- •22.Clinically relevant electrocardiogram (ECG) abnormality.
- •23.Clinically significant abnormal laboratory test findings.
- •24.Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, or any other body system.
- •25.Subjects currently being treated or had been treated within the last 30 days with antidiuretics or alpha-1 noradrenergic blockers including antipsychotic medications which are potent alpha-1 adrenergic blockers (e.g., iloperidone, quetiapine).
- •26.Participation in any investigational drug study within 30 days prior to initial dose of study drug.
- •27.Donation of blood within 30 days prior to screening or plas
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