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

Alzheimer Disease Clinical Trial

— RAmP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918539
• Other study ID #: 18F-AV-45-A25
• Secondary ID: PRA Study Code:
• Status: Completed
• Start date: October 2016
• Est. completion date: October 18, 2017

Study information

• Verified date: October 2018
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Community Hospital of Anderson and Madison Country	Anderson	Indiana
United States	Doctors Clinical Research	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	American Health Network of Indiana	Avon	Indiana
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	Integrative Clinical Trials	Brooklyn	New York
United States	Ptak Alzheimer Research Center	Clearwater	Florida
United States	Wisdom Clinical Research Institute	Coral Gables	Florida
United States	Millenium Psychiatric Associates	Creve Coeur	Missouri
United States	Dayton Center for Neurological Disorders	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Mile High Research Center	Denver	Colorado
United States	Clinical Inquest Center	Dublin	Ohio
United States	Michigan State University	East Lansing	Michigan
United States	Rhode Island Mood and Memory Research Institute	East Providence	Rhode Island
United States	American Health Network of Indiana, LLC	Franklin	Indiana
United States	Neurology Center of North Orange County	Fullerton	California
United States	Arrowhead Internal Medicine, PC	Glendale	Arizona
United States	Adirondack Medical Research	Glens Falls	New York
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Direct Helpers Research	Hialeah	Florida
United States	Galiz Research	Hialeah	Florida
United States	Healing Touch C&C Research Inc	Hialeah	Florida
United States	Advanced Research Institute of Miami	Homestead	Florida
United States	Heights Doctors Clinic	Houston	Texas
United States	Yvonne Kew MD PLLC Neuro-Oncology Clinic	Houston	Texas
United States	Irvine Center for Clinical Research	Irvine	California
United States	Adler Institute for Advanced Imaging	Jenkintown	Pennsylvania
United States	Senior Clinical Trials, Inc.	Laguna Hills	California
United States	Neurological Associates of Long Island	Lake Success	New York
United States	FMC Science	Lampasas	Texas
United States	Las Vegas Medical Center	Las Vegas	Nevada
United States	Precision Clinical Research	Lauderdale Lakes	Florida
United States	The Clinical Research Group, Inc.	Lewisville	Texas
United States	Neurology Associates, PA	Maitland	Florida
United States	Amici Clinical Research	Martinsville	New Jersey
United States	Merritt Island Medical Research	Merritt Island	Florida
United States	Advanced Medical Research Institute (AMRI)	Miami	Florida
United States	Dade Research Center	Miami	Florida
United States	Homestead Associates in Research	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	United Clinical Research, Corp.	Miami	Florida
United States	Advance Research Development Solutions	Miami Lakes	Florida
United States	Dean Foundation for Health, Research and Education, Inc.	Middleton	Wisconsin
United States	Coastal Conneticut Research	New London	Connecticut
United States	Pearl Clinical Research	Norristown	Pennsylvania
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	Center for Neuro and Spine Inc. (CNS) - Main Office	Phoenix	Arizona
United States	Neurostudies.net, LLC	Port Charlotte	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Legacy Research Institute	Portland	Oregon
United States	National Clinical Research-Richmond, Inc.	Richmond	Virginia
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Suncoast Neuroscience Associates, Inc.	Saint Petersburg	Florida
United States	Texas Medical Research Associates, LLC	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Imaging Endpoints	Scottsdale	Arizona
United States	North Bay Neuroscience Institute	Sebastopol	California
United States	The Cognitive and Research Center of New Jersey	Springfield	New Jersey
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Center for Neurology and Spine	Sun City	Arizona
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	Advanced Memory Research Institute of NJ, PC	Toms River	New Jersey
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	Lovelance Scientific Resources, Inc.	Venice	Florida
United States	Neurology Specialists of Monmouth County, PA	West Long Branch	New Jersey
United States	Sand Lake Imaging, MRI Facility	Winter Park	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals	Eli Lilly and Company, PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Registry Participation	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.	Two years

External Links

•   Link to RAmP Registry website