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Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials (RAmP)

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ClinicalTrials.gov Identifier: NCT02918539
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
Eli Lilly and Company
PRA Health Sciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Alzheimer Disease Cognition Disorders Drug: florbetapir F 18 PET scan

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Study Type : Observational [Patient Registry]
Actual Enrollment : 317 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
Study Start Date : October 2016
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : October 18, 2017


Group/Cohort Intervention/treatment
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
Drug: 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 Name: Amyvid




Primary Outcome Measures :
  1. Patient Registry Participation [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have a) objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer's disease and b) a willingness to make available to Avid a preexisting amyloid scan that has been interpreted as positive, or if an amyloid scan is not available, a willingness to undergo amyloid scanning via the Florbetapir F 18 PET Scan Addendum, will be enrolled.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918539


Locations
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United States, Arizona
Arrowhead Internal Medicine, PC
Glendale, Arizona, United States, 85381
Center for Neuro and Spine Inc. (CNS) - Main Office
Phoenix, Arizona, United States, 85032
Imaging Endpoints
Scottsdale, Arizona, United States, 85258
Center for Neurology and Spine
Sun City, Arizona, United States, 85351
United States, Arkansas
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
United States, California
Neurology Center of North Orange County
Fullerton, California, United States, 92835
Irvine Center for Clinical Research
Irvine, California, United States, 92614
Senior Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Pacific Research Network
San Diego, California, United States, 92103
Syrentis Clinical Research
Santa Ana, California, United States, 92705
North Bay Neuroscience Institute
Sebastopol, California, United States, 95472
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Coastal Conneticut Research
New London, Connecticut, United States, 06320
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Ptak Alzheimer Research Center
Clearwater, Florida, United States, 33756
Wisdom Clinical Research Institute
Coral Gables, Florida, United States, 33134
Direct Helpers Research
Hialeah, Florida, United States, 33012
Healing Touch C&C Research Inc
Hialeah, Florida, United States, 33012
Galiz Research
Hialeah, Florida, United States, 33016
Advanced Research Institute of Miami
Homestead, Florida, United States, 33030
Precision Clinical Research
Lauderdale Lakes, Florida, United States, 33319
Neurology Associates, PA
Maitland, Florida, United States, 32751
Merritt Island Medical Research
Merritt Island, Florida, United States, 32952
Advance Research Development Solutions
Miami Lakes, Florida, United States, 33014
Homestead Associates in Research
Miami, Florida, United States, 33032
Dade Research Center
Miami, Florida, United States, 33135
United Clinical Research, Corp.
Miami, Florida, United States, 33155
Advanced Medical Research Institute (AMRI)
Miami, Florida, United States, 33174
New Horizon Research Center
Miami, Florida, United States, 33175
Bravo Health Care Center
North Bay Village, Florida, United States, 33141
Laszlo J. Mate, MD
North Palm Beach, Florida, United States, 33408
Pines Care Research Center
Pembroke Pines, Florida, United States, 33026
Neurostudies.net, LLC
Port Charlotte, Florida, United States, 33952
Progressive Medical Research
Port Orange, Florida, United States, 32127
Suncoast Neuroscience Associates, Inc.
Saint Petersburg, Florida, United States, 33713
Olympian Clinical Research - South Tampa Office
Tampa, Florida, United States, 33609
Tampa Neurology Associates
Tampa, Florida, United States, 33609
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
Lovelance Scientific Resources, Inc.
Venice, Florida, United States, 34292
Sand Lake Imaging, MRI Facility
Winter Park, Florida, United States, 32789
United States, Georgia
Doctors Clinical Research
Atlanta, Georgia, United States, 30312
iResearch Atlanta
Decatur, Georgia, United States, 30030
United States, Indiana
Community Hospital of Anderson and Madison Country
Anderson, Indiana, United States, 46011
American Health Network of Indiana
Avon, Indiana, United States, 46123
American Health Network of Indiana, LLC
Franklin, Indiana, United States, 46131
United States, Kansas
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204
Spectrum Clinical Research
Baltimore, Maryland, United States, 21228
United States, Massachusetts
Boston Center for Memory
Brookline, Massachusetts, United States, 02467
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Millenium Psychiatric Associates
Creve Coeur, Missouri, United States, 63141
United States, Nevada
Las Vegas Medical Center
Las Vegas, Nevada, United States, 89113
United States, New Jersey
Amici Clinical Research
Martinsville, New Jersey, United States, 08836
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States, 07801
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County, PA
West Long Branch, New Jersey, United States, 07764
United States, New York
Integrative Clinical Trials
Brooklyn, New York, United States, 11229
Adirondack Medical Research
Glens Falls, New York, United States, 12801
Neurological Associates of Long Island
Lake Success, New York, United States, 11042
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Dayton Center for Neurological Disorders
Dayton, Ohio, United States, 45429
Clinical Inquest Center
Dublin, Ohio, United States, 43017
United States, Oklahoma
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Legacy Research Institute
Portland, Oregon, United States, 97210
United States, Pennsylvania
Adler Institute for Advanced Imaging
Jenkintown, Pennsylvania, United States, 19046
Pearl Clinical Research
Norristown, Pennsylvania, United States, 19401
United States, Rhode Island
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States, 02914
United States, Texas
Heights Doctors Clinic
Houston, Texas, United States, 77008
Yvonne Kew MD PLLC Neuro-Oncology Clinic
Houston, Texas, United States, 77030
FMC Science
Lampasas, Texas, United States, 76550
The Clinical Research Group, Inc.
Lewisville, Texas, United States, 76117
Texas Medical Research Associates, LLC
San Antonio, Texas, United States, 78238
United States, Virginia
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States, 23294
United States, Wisconsin
Dean Foundation for Health, Research and Education, Inc.
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Avid Radiopharmaceuticals
Eli Lilly and Company
PRA Health Sciences
Investigators
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Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
Additional Information:

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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02918539    
Other Study ID Numbers: 18F-AV-45-A25
PRA Study Code: 446601 ( Other Identifier: PRA Health Sciences )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders