A Prospective, Multicentric, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy along with Standard Supportive Care in Subjects of mild to moderate Alzheimers disease.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Number of adverse events (AEs) and serious adverse events (SAEs), number of subjects with AEs/SAEs, changes in vital signs and laboratory examinations.
研究概览
简要总结
This is a prospective, multicentric, randomized, double blind, placebo controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 therapy along with standard supportive care in subjects with mild to moderate AD. A total of 80 subjects (40 in each group) will be enrolled in this study. The enrolment period of the study will be approximately 12 months and total duration of the study will be approximately 18 months. For an individual subject, duration of the study will be 6 months (160 days), including 8 study visits: visit 1/Day 1 (screening/baseline visit), visit 2/Day 2-5 (treatment visit), visit 3/Day 30±3 (treatment visit), visit 4/Day 60±3 (treatment visit), visit 5/Day 90±3 (treatment and assessment visit), visit 6/Day 120±3 (treatment visit), visit 7/Day 150±3 (treatment visit) and final visit 8/End of study Day 157 to 160 (Follow-up visit). At visit 2, subjects will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria.
Group 1: PMZ-1620 + Standard of care
Group 2: Placebo + Standard of care
After randomization, subjects will be administered with either PMZ-1620 or Placebo, once in a month for 6 months. Three doses of PMZ-1620/Placebo (each dose of 0.3 μg/kg body weight) will be administered as an IV bolus over one minute at an interval of 3±1 hours once in a month (total dose/day: 0.9 μg/kg body weight). Dose will be repeated every month for 6 months post randomization. In both treatment groups, subjects will be provided the best standard of care. Standard of care to be provided to the subjects shall be the one used in the particular hospital setup. Each subject will be monitored closely throughout his/her admission for the qualifying mild to moderate AD and will be followed for 6 months from randomization. Each subject will be assessed for efficacy and safety parameters over 6 months from randomization at a clinic visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females aged 45 years through 85 years (have not had their 86th birthday)
- •Men and women with a diagnosis of Alzheimer’s disease according to the clinical criteria
- •Women must be of non-childbearing potential, surgically sterile, or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
- •Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)
- •Absence of major depressive disease according to Geriatric Depression Scale (GDS) of < 5
- •Previous decline in cognition for more than six months as documented in subject’s medical records
- •Subject, who are on stable treatment with any of AD drugs are also eligible to participate in this study
- •Formal education for eight or more years
- •Subjects living at home or nursing home setting, without continuous nursing care
- •General health status acceptable for participation in a 6-months clinical trial
- •A caregiver available and living in the same household or interacting with the subject a sufficient time each week and available if necessary to assure administration of drug 14.
排除标准
- •1.Subjects who have a Mini Mental State Examination (MMSE) score of <
- •2.Subjects who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the study, or would be likely to preclude participation in a drug development trial.
- •3.A current Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of active major depression, schizophrenia or bipolar disorder.
- •4.Other infectious, metabolic or systemic diseases affecting the central nervous system.
- •5.Subjects who have participated in a clinical trial investigating an anti-amyloid agent.
- •6.Subjects who are currently participating in a clinical trial with an investigational drug.
- •8.Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the subject or put the subject at special risk.
- •9.History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma).
- •10.Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of screening.
- •11.Clinical or laboratory findings consistent with: a.
- •Other primary degenerative dementia, b.
- •Other neurodegenerative condition c.
- •Seizure disorder
- •Subjects, who are already taking sedatives, antidepressants, antipsychotics and antihistaminic medications.
结局指标
主要结局
Number of adverse events (AEs) and serious adverse events (SAEs), number of subjects with AEs/SAEs, changes in vital signs and laboratory examinations.
时间窗: 6 months
次要结局
- Statistically relevant changes in clinical progression of AD as measured by MMSE(After 3 and 6 months of treatment.)
- Statistically relevant changes in NPI Score(After 3 and 6 months of treatment)
- Statistically relevant changes in ADAS-Cog(After 3 and 6 months of treatment)
- Statistically relevant changes in AD symptom progression of dementing process of hippocampal atrophy using MRI/CT(Before and at the end of study)
- Statistically relevant changes in electroencephalogram(EEG) of brain changes in AD symptom progression(After 3 and 6 months of treatment)
- Physical examinations of AD symptom progression(In every visits)