Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
- Conditions
- Alzheimer DiseaseCognition Disorders
- Interventions
- Drug: florbetapir F 18 PET scan
- Registration Number
- NCT02918539
- Lead Sponsor
- Avid Radiopharmaceuticals
- Brief Summary
This registry will be used to identify patients who have etiology diagnosed or suspected to be Alzheimer's disease and positive amyloid scans, and have indicated their interest in being contacted for an Eli Lilly and Company (Lilly) Alzheimer's Disease drug research trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 317
- Male or female patients ≥ 50 years of age at the time of consent;
- 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.
- Patients who have a Mini Mental State Examination (MMSE) score of < 16;
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RAmP Registry Patients florbetapir F 18 PET scan 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
- Primary Outcome Measures
Name Time Method Patient Registry Participation Two years There is no formal hypothesis to test in this registry study. The registry will collect contact information of amyloid positive patients with cognitive impairment who have indicated interest in being contacted for a Lilly AD drug research trial. The primary outcome measure to be reported is the total number of participants in the registry.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (75)
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Advance Research Development Solutions
🇺🇸Miami Lakes, Florida, United States
Coastal Conneticut Research
🇺🇸New London, Connecticut, United States
Direct Helpers Research
🇺🇸Hialeah, Florida, United States
Senior Clinical Trials, Inc.
🇺🇸Laguna Hills, California, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Imaging Endpoints
🇺🇸Scottsdale, Arizona, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Arrowhead Internal Medicine, PC
🇺🇸Glendale, Arizona, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
North Bay Neuroscience Institute
🇺🇸Sebastopol, California, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Healing Touch C&C Research Inc
🇺🇸Hialeah, Florida, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸Saint Petersburg, Florida, United States
Neurostudies.net, LLC
🇺🇸Port Charlotte, Florida, United States
United Clinical Research, Corp.
🇺🇸Miami, Florida, United States
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Neurological Associates of Long Island
🇺🇸Lake Success, New York, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States
Center for Neuro and Spine Inc. (CNS) - Main Office
🇺🇸Phoenix, Arizona, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Homestead Associates in Research
🇺🇸Miami, Florida, United States
Heights Doctors Clinic
🇺🇸Houston, Texas, United States
Dade Research Center
🇺🇸Miami, Florida, United States
Doctors Clinical Research
🇺🇸Atlanta, Georgia, United States
Spectrum Clinical Research
🇺🇸Baltimore, Maryland, United States
Yvonne Kew MD PLLC Neuro-Oncology Clinic
🇺🇸Houston, Texas, United States
Las Vegas Medical Center
🇺🇸Las Vegas, Nevada, United States
Legacy Research Institute
🇺🇸Portland, Oregon, United States
Ptak Alzheimer Research Center
🇺🇸Clearwater, Florida, United States
Center for Neurology and Spine
🇺🇸Sun City, Arizona, United States
Precision Clinical Research
🇺🇸Lauderdale Lakes, Florida, United States
Sand Lake Imaging, MRI Facility
🇺🇸Winter Park, Florida, United States
American Health Network of Indiana, LLC
🇺🇸Franklin, Indiana, United States
Lovelance Scientific Resources, Inc.
🇺🇸Venice, Florida, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
Dayton Center for Neurological Disorders
🇺🇸Dayton, Ohio, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Wisdom Clinical Research Institute
🇺🇸Coral Gables, Florida, United States
Galiz Research
🇺🇸Hialeah, Florida, United States
Advanced Research Institute of Miami
🇺🇸Homestead, Florida, United States
Boston Center for Memory
🇺🇸Brookline, Massachusetts, United States
Neurology Associates, PA
🇺🇸Maitland, Florida, United States
Merritt Island Medical Research
🇺🇸Merritt Island, Florida, United States
Bravo Health Care Center
🇺🇸North Bay Village, Florida, United States
Advanced Medical Research Institute (AMRI)
🇺🇸Miami, Florida, United States
Pines Care Research Center
🇺🇸Pembroke Pines, Florida, United States
Laszlo J. Mate, MD
🇺🇸North Palm Beach, Florida, United States
Clinical Inquest Center
🇺🇸Dublin, Ohio, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
American Health Network of Indiana
🇺🇸Avon, Indiana, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Community Hospital of Anderson and Madison Country
🇺🇸Anderson, Indiana, United States
Millenium Psychiatric Associates
🇺🇸Creve Coeur, Missouri, United States
Adirondack Medical Research
🇺🇸Glens Falls, New York, United States
Amici Clinical Research
🇺🇸Martinsville, 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
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
The Clinical Research Group, Inc.
🇺🇸Lewisville, Texas, United States
Texas Medical Research Associates, LLC
🇺🇸San Antonio, Texas, United States
Dean Foundation for Health, Research and Education, Inc.
🇺🇸Middleton, Wisconsin, 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
National Clinical Research-Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Adler Institute for Advanced Imaging
🇺🇸Jenkintown, Pennsylvania, United States
Pearl Clinical Research
🇺🇸Norristown, Pennsylvania, United States
FMC Science
🇺🇸Lampasas, Texas, United States