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 Alzheimer's Disease

PMZ-1620/CLINICAL-2.2/2017

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 Alzheimer's disease.

2018-03-23

2022-12-20

2023-01-06

Completed

Early phase I

80

Inclusion Criteria: 1. Adult males or females Aged 45 years through 85 years (have not had their 86th birthday) 2. Men and women with a diagnosis of Alzheimer's disease according to the clinical criteria 3. 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 4. Able to give consent for participation on their own or through their Legally Acceptable Representative 5. MRI/CT scan assessment within six months before baseline, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions 6. MMSE score in between 11 to 26 in case of mild to moderate stage of Alzheimer's disease 6. Absence of major depressive disease according to Geriatric Depression Scale (GDS) of \< 5 7. Previous decline in cognition for more than six months as documented in subject's medical records 8. Subject, who are on stable treatment with any of AD drugs are also eligible to participate in this study 9. Formal education for eight or more years 10. Subjects living at home or nursing home setting, without continuous nursing care 11. General health status acceptable for participation in a 6-months clinical trial 12. 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 13. Subjects with any other chronic conditions are stable and undergoing appropriate treatment Exclusion Criteria: 1. Subjects who have a Mini Mental State Examination (MMSE) score of \< 10 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 7. Subjects who, in the opinion of the physician, are otherwise unsuitable for this study 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: 1. Other primary degenerative dementia, 2. Other neurodegenerative condition 3. Seizure disorder 12. Subjects, who are already taking sedatives, antidepressants, antipsychotics and antihistaminic medications

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour (total dose/day: 0.9 µg/kg body weight). The same dosing regimen will be repeated every month for 6 months post randomization.\n\nIn control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1 post randomization. The same dosing regimen will be repeated every month for 6 months post randomization.\n\nIn both treatment groups, subjects will be provided the best available standard of care.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

2023-01-12