Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
NCT ID: NCT02918539
Last Updated: 2018-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
317 participants
OBSERVATIONAL
2016-10-31
2017-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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RAmP Registry Patients
Patients who have a) objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer's disease and b) a positive amyloid scan from either an existing amyloid scan that has been interpreted as positive or a florbetapir F 18 PET scan via protocol addendum
florbetapir F 18 PET scan
For those patients who do not have an existing amyloid scan, each will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 followed by a Positron Emission Tomography (PET) Scan to determine amyloid status
Interventions
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florbetapir F 18 PET scan
For those patients who do not have an existing amyloid scan, each will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 followed by a Positron Emission Tomography (PET) Scan to determine amyloid status
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer's disease;
* Patients who are willing to make available to Avid a positive amyloid scan, or if an amyloid scan is not available, are willing to undergo amyloid scanning via the Florbetapir F 18 PET Scan Addendum;
* Patients who are willing to be contacted for possible participation in Lilly drug research trials targeting Alzheimer's disease;
* Patients who give informed consent or have a legally authorized representative (LAR) to consent for enrollment; and
* Patients who have a partner (informant) who is willing to participate as a source of information and has at least weekly contact with the patient (contact can be inperson, via telephone or electronic communication). The informant must have sufficient contact such that the referring physician feels the informant can provide meaningful information about the patient.
Exclusion Criteria
* Patients who have an amyloid-negative PET scan (either a historical scan or scan via the Florbetapir F 18 PET Scan Addendum);
* Patients who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the registry, or would be likely to preclude participation in a drug research trial;
* Patients who are currently participating in a clinical trial with an investigational agent; or
* Patients who, in the opinion of the physician, are otherwise unsuitable for this registry.
50 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
PRA Health Sciences
INDUSTRY
Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_CHAIR
Avid Radiopharmaceuticals, Inc.
Locations
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Arrowhead Internal Medicine, PC
Glendale, Arizona, United States
Center for Neuro and Spine Inc. (CNS) - Main Office
Phoenix, Arizona, United States
Imaging Endpoints
Scottsdale, Arizona, United States
Center for Neurology and Spine
Sun City, Arizona, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Neurology Center of North Orange County
Fullerton, California, United States
Irvine Center for Clinical Research
Irvine, California, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, United States
Pacific Research Network
San Diego, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
North Bay Neuroscience Institute
Sebastopol, California, United States
Mile High Research Center
Denver, Colorado, United States
Coastal Conneticut Research
New London, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Ptak Alzheimer Research Center
Clearwater, Florida, United States
Wisdom Clinical Research Institute
Coral Gables, Florida, United States
Direct Helpers Research
Hialeah, Florida, United States
Healing Touch C&C Research Inc
Hialeah, Florida, United States
Galiz Research
Hialeah, Florida, United States
Advanced Research Institute of Miami
Homestead, Florida, United States
Precision Clinical Research
Lauderdale Lakes, Florida, United States
Neurology Associates, PA
Maitland, Florida, United States
Merritt Island Medical Research
Merritt Island, Florida, United States
Homestead Associates in Research
Miami, Florida, United States
Dade Research Center
Miami, Florida, United States
United Clinical Research, Corp.
Miami, Florida, United States
Advanced Medical Research Institute (AMRI)
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Advance Research Development Solutions
Miami Lakes, Florida, United States
Bravo Health Care Center
North Bay Village, Florida, United States
Laszlo J. Mate, MD
North Palm Beach, Florida, United States
Pines Care Research Center
Pembroke Pines, Florida, United States
Neurostudies.net, LLC
Port Charlotte, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
Olympian Clinical Research - South Tampa Office
Tampa, Florida, United States
Tampa Neurology Associates
Tampa, Florida, United States
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Lovelance Scientific Resources, Inc.
Venice, Florida, United States
Sand Lake Imaging, MRI Facility
Winter Park, Florida, United States
Doctors Clinical Research
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
Community Hospital of Anderson and Madison Country
Anderson, Indiana, United States
American Health Network of Indiana
Avon, Indiana, United States
American Health Network of Indiana, LLC
Franklin, Indiana, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
Spectrum Clinical Research
Baltimore, Maryland, United States
Boston Center for Memory
Brookline, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Millenium Psychiatric Associates
Creve Coeur, Missouri, United States
Las Vegas Medical Center
Las Vegas, Nevada, United States
Amici Clinical Research
Martinsville, New Jersey, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, United States
Neurology Specialists of Monmouth County, PA
West Long Branch, New Jersey, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Adirondack Medical Research
Glens Falls, New York, United States
Neurological Associates of Long Island
Lake Success, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Dayton Center for Neurological Disorders
Dayton, Ohio, United States
Clinical Inquest Center
Dublin, Ohio, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
Legacy Research Institute
Portland, Oregon, United States
Adler Institute for Advanced Imaging
Jenkintown, Pennsylvania, United States
Pearl Clinical Research
Norristown, Pennsylvania, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States
Heights Doctors Clinic
Houston, Texas, United States
Yvonne Kew MD PLLC Neuro-Oncology Clinic
Houston, Texas, United States
FMC Science
Lampasas, Texas, United States
The Clinical Research Group, Inc.
Lewisville, Texas, United States
Texas Medical Research Associates, LLC
San Antonio, Texas, United States
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States
Dean Foundation for Health, Research and Education, Inc.
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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PRA Study Code: 446601
Identifier Type: OTHER
Identifier Source: secondary_id
18F-AV-45-A25
Identifier Type: -
Identifier Source: org_study_id
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