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 โฅ 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
Trial Locations
- Locations (75)
JEM Research Institute
๐บ๐ธAtlantis, Florida, United States
Advance Research Development Solutions
๐บ๐ธMiami Lakes, Florida, United States
Coastal Conneticut Research
๐บ๐ธNew London, Connecticut, United States
Direct Helpers Research
๐บ๐ธHialeah, Florida, United States
Senior Clinical Trials, Inc.
๐บ๐ธLaguna Hills, California, United States
Hattiesburg Clinic
๐บ๐ธHattiesburg, Mississippi, United States
Imaging Endpoints
๐บ๐ธScottsdale, Arizona, United States
Progressive Medical Research
๐บ๐ธPort Orange, Florida, United States
Arrowhead Internal Medicine, PC
๐บ๐ธGlendale, Arizona, United States
Woodland Research Northwest
๐บ๐ธRogers, Arkansas, United States
North Bay Neuroscience Institute
๐บ๐ธSebastopol, California, United States
Irvine Center for Clinical Research
๐บ๐ธIrvine, California, United States
Syrentis Clinical Research
๐บ๐ธSanta Ana, California, United States
Healing Touch C&C Research Inc
๐บ๐ธHialeah, Florida, United States
Neurology Center of North Orange County
๐บ๐ธFullerton, California, United States
Suncoast Neuroscience Associates, Inc.
๐บ๐ธSaint Petersburg, Florida, United States
Neurostudies.net, LLC
๐บ๐ธPort Charlotte, Florida, United States
United Clinical Research, Corp.
๐บ๐ธMiami, Florida, United States
The Cognitive and Research Center of New Jersey
๐บ๐ธSpringfield, New Jersey, United States
Richmond Behavioral Associates
๐บ๐ธStaten Island, New York, United States
Neurological Associates of Long Island
๐บ๐ธLake Success, New York, United States
New Horizon Research Center
๐บ๐ธMiami, Florida, United States
Mile High Research Center
๐บ๐ธDenver, Colorado, United States
Sheppard Pratt Health System
๐บ๐ธBaltimore, Maryland, United States
Center for Neuro and Spine Inc. (CNS) - Main Office
๐บ๐ธPhoenix, Arizona, United States
Pacific Research Network
๐บ๐ธSan Diego, California, United States
Homestead Associates in Research
๐บ๐ธMiami, Florida, United States
Heights Doctors Clinic
๐บ๐ธHouston, Texas, United States
Dade Research Center
๐บ๐ธMiami, Florida, United States
Doctors Clinical Research
๐บ๐ธAtlanta, Georgia, United States
Spectrum Clinical Research
๐บ๐ธBaltimore, Maryland, United States
Yvonne Kew MD PLLC Neuro-Oncology Clinic
๐บ๐ธHouston, Texas, United States
Las Vegas Medical Center
๐บ๐ธLas Vegas, Nevada, United States
Legacy Research Institute
๐บ๐ธPortland, Oregon, United States
Ptak Alzheimer Research Center
๐บ๐ธClearwater, Florida, United States
Center for Neurology and Spine
๐บ๐ธSun City, Arizona, United States
Precision Clinical Research
๐บ๐ธLauderdale Lakes, Florida, United States
Sand Lake Imaging, MRI Facility
๐บ๐ธWinter Park, Florida, United States
American Health Network of Indiana, LLC
๐บ๐ธFranklin, Indiana, United States
Lovelance Scientific Resources, Inc.
๐บ๐ธVenice, Florida, United States
Michigan State University
๐บ๐ธEast Lansing, Michigan, United States
Integrative Clinical Trials
๐บ๐ธBrooklyn, New York, United States
Dayton Center for Neurological Disorders
๐บ๐ธDayton, Ohio, United States
Rhode Island Mood and Memory Research Institute
๐บ๐ธEast Providence, Rhode Island, United States
Wisdom Clinical Research Institute
๐บ๐ธCoral Gables, Florida, United States
Galiz Research
๐บ๐ธHialeah, Florida, United States
Advanced Research Institute of Miami
๐บ๐ธHomestead, Florida, United States
Boston Center for Memory
๐บ๐ธBrookline, Massachusetts, United States
Neurology Associates, PA
๐บ๐ธMaitland, Florida, United States
Merritt Island Medical Research
๐บ๐ธMerritt Island, Florida, United States
Bravo Health Care Center
๐บ๐ธNorth Bay Village, Florida, United States
Advanced Medical Research Institute (AMRI)
๐บ๐ธMiami, Florida, United States
Pines Care Research Center
๐บ๐ธPembroke Pines, Florida, United States
Laszlo J. Mate, MD
๐บ๐ธNorth Palm Beach, Florida, United States
Clinical Inquest Center
๐บ๐ธDublin, Ohio, United States
Cotton O'Neil Clinical Research Center
๐บ๐ธTopeka, Kansas, United States
American Health Network of Indiana
๐บ๐ธAvon, Indiana, United States
iResearch Atlanta
๐บ๐ธDecatur, Georgia, United States
Community Hospital of Anderson and Madison Country
๐บ๐ธAnderson, Indiana, United States
Millenium Psychiatric Associates
๐บ๐ธCreve Coeur, Missouri, United States
Adirondack Medical Research
๐บ๐ธGlens Falls, New York, United States
Amici Clinical Research
๐บ๐ธMartinsville, New Jersey, United States
Advanced Memory Research Institute of NJ, PC
๐บ๐ธToms River, New Jersey, United States
Neurology Specialists of Monmouth County, PA
๐บ๐ธWest Long Branch, New Jersey, United States
Tulsa Clinical Research, LLC
๐บ๐ธTulsa, Oklahoma, United States
The Clinical Research Group, Inc.
๐บ๐ธLewisville, Texas, United States
Texas Medical Research Associates, LLC
๐บ๐ธSan Antonio, Texas, United States
Dean Foundation for Health, Research and Education, Inc.
๐บ๐ธMiddleton, Wisconsin, United States
Olympian Clinical Research - South Tampa Office
๐บ๐ธTampa, Florida, United States
Tampa Neurology Associates
๐บ๐ธTampa, Florida, United States
University of South Florida Health Byrd Alzheimer's Institute
๐บ๐ธTampa, Florida, United States
National Clinical Research-Richmond, Inc.
๐บ๐ธRichmond, Virginia, United States
Adler Institute for Advanced Imaging
๐บ๐ธJenkintown, Pennsylvania, United States
Pearl Clinical Research
๐บ๐ธNorristown, Pennsylvania, United States
FMC Science
๐บ๐ธLampasas, Texas, United States