Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 5:40 PM
Study NCT ID:
NCT00100334
Status:
COMPLETED
Last Update Posted:
2006-09-19
First Post:
2004-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2005-08'}, 'lastUpdateSubmitDate': '2006-09-18', 'studyFirstSubmitDate': '2004-12-29', 'studyFirstSubmitQcDate': '2004-12-29', 'lastUpdatePostDateStruct': {'date': '2006-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety will be assessed through the occurrence of clinical adverse events and the occurrence of clinically significant changes from baseline.'}]}, 'conditionsModule': {'keywords': ["Alzheimer's Disease"], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This is a single-center, double-blind, inpatient study followed by an outpatient, placebo-controlled, multiple-IV injection evaluation of the safety and tolerability of PPI-1019 in subjects with mild-moderate Alzheimer's disease (AD). The primary objective of the study is to assess the safety of multiple IV injections of PPI-1019 in subjects with mild-moderate Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has the ability to understand the requirements of the study, provide written informed consent, and abide by the requirements of the study. In addition, a member of the subject\'s family or a legally authorized representative must consent to the subject\'s participation in the study.\n* Subject has a caregiver willing to assist the subject\'s involvement in the study.\n* Subject is a male or female between the ages of 50 and 80 with a body mass index (BMI) below 31. Females must be post-menopausal at least 1 year or surgically sterilized.\n* Subject must have a cognitive deficit present for at least 1 year and meet DSM -IV criteria for Alzheimer\'s disease and meet National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer\'s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for the presence of probable Alzheimer\'s disease.\n* Subject\'s severity of Alzheimer\'s disease must be mild-moderate, documented with a Mini Mental State Exam (MMSE) score of 12-26.\n* Subject has a computerized tomography (CT) scan or magnetic resonance imaging (MRI) within the prior 12 months which is compatible with a diagnosis of probable AD.\n* If a subject is being treated for Alzheimer\'s disease, it must be with a single cholinesterase inhibitor (donepezil, rivastigmine, or galantamine), with or without memantine, and with a dose which has been stable for at least 3 months prior to dosing.\n* Subject performance status is ≤ 3 on items 1 through 5 and ≤ 2 on item 6 from the Degree of Disability Section of the "Rapid Disability Scale-2"\n* Subject agrees not to donate blood or blood products while participating in this study and for at least 60 days after discontinuing from the study.\n\nExclusion Criteria:\n\n* Subject has participated in a clinical trial of another investigational drug or device, or has taken any experimental drug within 30 days prior to admission to the Phase 1 unit. (Subjects previously enrolled in 1019-03-01 may be enrolled in 1019-04-01, only after a wash-out period of 45 days.)\n* Subject has a history compatible with vascular dementia as evidenced by a score of 5 or greater on the modified Hachinski Ischemia Scale.\n* Subject has evidence of clinically significant unstable cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months (as determined by medical history, ECG results, chest x-ray, or physical examination).\n* Subject performance status is \\> 3 on items 1 through 5 and \\> 2 on item 6 from the Degree of Disability Section of the "Rapid Disability Scale-2."\n* Subject has diabetes that requires oral antidiabetic therapy or insulin.\n* Subject has a systolic blood pressure (sitting) of greater than 160 mmHg, a diastolic (sitting) greater than 95 mmHg, a decrease in systolic blood pressure of more than 30 mmHg upon standing for 2 minutes from a sitting or supine position, a pulse (sitting or supine) less than 50 or greater than 85.\n* Subject has any visual, hearing, or communication disabilities impairing his/her ability to participate in the study.\n* Subject is being treated with anticholinergics and/or clinically relevant cytochrome P450 3A4 inducers/inhibitors. The use of other concomitant medications for stable medical conditions is acceptable provided drug and dosage are stable for at least 4 weeks prior to dosing.\n* Subject is currently taking herbal supplements which interfere with drug metabolism, e.g. St. John\'s wort, ginkgo biloba.\n* Subject has tested positive for drugs of abuse (amphetamines, barbiturates, cocaine, phencyclidine, or cannabinoids) on screening or Day -1\n* Subject has a current or past medical history of alcohol abuse.\n* Subject has any elevations (\\> 1.2 x ULN) on screening or Day -1 for ALT, AST, bilirubin, creatinine, blood urea nitrogen, or alkaline phosphatase.\n* Subject has any other screening or Day -1 laboratory values outside the normal ranges that are deemed clinically significant by the investigator.'}, 'identificationModule': {'nctId': 'NCT00100334', 'briefTitle': "Safety Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'PRAECIS Pharmaceuticals Inc.'}, 'officialTitle': "Multiple Dose Safety and Preliminary Pharmacodynamic Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': '1019-04-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PPI-1019 (APAN)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92675', 'city': 'San Juan Capistrano', 'state': 'California', 'country': 'United States', 'facility': 'Silverado Senior Living', 'geoPoint': {'lat': 33.50169, 'lon': -117.66255}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PRAECIS Pharmaceuticals Inc.', 'class': 'INDUSTRY'}}}}