Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00693004
Status:
TERMINATED
Last Update Posted:
2009-07-30
First Post:
2008-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of PRX-03140 Monotherapy in Subjects With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-28', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cognitive subscale."}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or Women with a clinical diagnosis of Probable AD\n* MMSE score 16 to 24 inclusive\n* Age \\>50 and \\<90 years\n* Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 months\n* Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)\n* No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia\n* No diagnosis of vascular dementia\n* No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for \\>6 months may be eligible\n* No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function\n* No cognitive rehabilitation within 6 months of the study\n* Subject has a regular caregiver willing to attend all study visits\n* Signed informed consent by the subject (and legal guardian, if applicable)\n\nExclusion Criteria:\n\n* No history of drug or alcohol abuse\n* No clinically significant laboratory abnormalities or medical history\n* No investigational drug within 30 days of Randomization\n* Intolerance or allergy to cholinesterase inhibitors\n* Cannot have been on cholinesterase inhibitors for AD for \\> 2 years\n* If have been on cholinesterase inhibitors for \\< 2 years, must have been discontinued \\>= 2 months prior to randomization\n* Cannot have received memantine within 2 months\n* No clinically significant ECG abnormalities prior to randomization\n* No history of uncontrolled seizure disorder within 12 months\n* Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine\n* No history of malignancy within 3 years of randomization\n* Women cannot be pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00693004', 'briefTitle': "Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Epix Pharmaceuticals, Inc.'}, 'officialTitle': "A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'Protocol 03140-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PRX-03140', 'interventionNames': ['Drug: PRX-03140']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'donepezil', 'interventionNames': ['Drug: Donepezil']}], 'interventions': [{'name': 'PRX-03140', 'type': 'DRUG', 'armGroupLabels': ['PRX-03140']}, {'name': 'Donepezil', 'type': 'DRUG', 'armGroupLabels': ['donepezil']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'PsyPharma Clinical Research, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741-3537', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists, PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Neuroscience Medical Group', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'California Neuroscience Research Medical Group, Inc.', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bradenton Research Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Brain Matters Research', 'geoPoint': 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'facility': 'Roskamp Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Four Rivers Clinical Research', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '71104', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'J. Gary Booker, MD, APMC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Neurology', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '02062', 'city': 'Norwood', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The ICPS Group', 'geoPoint': {'lat': 42.19454, 'lon': -71.1995}}, {'zip': '08759', 'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'facility': "Alzheimer's Research Corporation", 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Global Medical Institutes', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Social Psychiatry Research Institute', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Behavioral Medical Research of Staten Island', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Neurological Institute, P.A.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28655', 'city': 'Morgantown', 'state': 'North Carolina', 'country': 'United States', 'facility': 'MedArk', 'geoPoint': {'lat': 36.12208, 'lon': -79.42891}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology and Neuroscience Center of Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tulsa Clinical Research, LLC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Mood and Memory Research Institute', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Todd Swick, MD, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The Memory Clinic', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23185', 'city': 'Williamsburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Center for Excellence in Aging and Geriatric Health', 'geoPoint': {'lat': 37.2707, 'lon': -76.70746}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epix Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elkan R. Gamzu, PhD', 'oldOrganization': 'EPIX Pharmaceuticals, Inc.'}}}}