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

NCT02918539 | Completed

• 2 other identifiers: 18F-AV-45-A25PRA Study Code: 446601
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 75

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.

Conditions

Alzheimer Disease; Cognition Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

florbetapir F 18 PET scan DRUG

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

Also known as: Amyvid

RAmP Registry Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead
• Eli Lilly and Company: collaborator
• PRA Health Sciences: collaborator

Study Sites (75)

Arrowhead Internal Medicine, PC

Glendale, Arizona, 85381, United States

Location

Center for Neuro and Spine Inc. (CNS) - Main Office

Phoenix, Arizona, 85032, United States

Location

Imaging Endpoints

Scottsdale, Arizona, 85258, United States

Location

Center for Neurology and Spine

Sun City, Arizona, 85351, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

Irvine Center for Clinical Research

Irvine, California, 92614, United States

Location

Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

North Bay Neuroscience Institute

Sebastopol, California, 95472, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

Coastal Conneticut Research

New London, Connecticut, 06320, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Ptak Alzheimer Research Center

Clearwater, Florida, 33756, United States

Location

Wisdom Clinical Research Institute

Coral Gables, Florida, 33134, United States

Location

Direct Helpers Research

Hialeah, Florida, 33012, United States

Location

Healing Touch C&C Research Inc

Hialeah, Florida, 33012, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Advanced Research Institute of Miami

Homestead, Florida, 33030, United States

Location

Precision Clinical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Neurology Associates, PA

Maitland, Florida, 32751, United States

Location

Merritt Island Medical Research

Merritt Island, Florida, 32952, United States

Location

Homestead Associates in Research

Miami, Florida, 33032, United States

Location

Dade Research Center

Miami, Florida, 33135, United States

Location

United Clinical Research, Corp.

Miami, Florida, 33155, United States

Location

Advanced Medical Research Institute (AMRI)

Miami, Florida, 33174, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Advance Research Development Solutions

Miami Lakes, Florida, 33014, United States

Location

Bravo Health Care Center

North Bay Village, Florida, 33141, United States

Location

Laszlo J. Mate, MD

North Palm Beach, Florida, 33408, United States

Location

Pines Care Research Center

Pembroke Pines, Florida, 33026, United States

Location

Neurostudies.net, LLC

Port Charlotte, Florida, 33952, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

Olympian Clinical Research - South Tampa Office

Tampa, Florida, 33609, United States

Location

Tampa Neurology Associates

Tampa, Florida, 33609, United States

Location

University of South Florida Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

Location

Lovelance Scientific Resources, Inc.

Venice, Florida, 34292, United States

Location

Sand Lake Imaging, MRI Facility

Winter Park, Florida, 32789, United States

Location

Doctors Clinical Research

Atlanta, Georgia, 30312, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Community Hospital of Anderson and Madison Country

Anderson, Indiana, 46011, United States

Location

American Health Network of Indiana

Avon, Indiana, 46123, United States

Location

American Health Network of Indiana, LLC

Franklin, Indiana, 46131, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Location

Spectrum Clinical Research

Baltimore, Maryland, 21228, United States

Location

Boston Center for Memory

Brookline, Massachusetts, 02467, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Millenium Psychiatric Associates

Creve Coeur, Missouri, 63141, United States

Location

Las Vegas Medical Center

Las Vegas, Nevada, 89113, United States

Location

Amici Clinical Research

Martinsville, New Jersey, 08836, United States

Location

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07801, United States

Location

Advanced Memory Research Institute of NJ, PC

Toms River, New Jersey, 08755, United States

Location

Neurology Specialists of Monmouth County, PA

West Long Branch, New Jersey, 07764, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

Adirondack Medical Research

Glens Falls, New York, 12801, United States

Location

Neurological Associates of Long Island

Lake Success, New York, 11042, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Dayton Center for Neurological Disorders

Dayton, Ohio, 45429, United States

Location

Clinical Inquest Center

Dublin, Ohio, 43017, United States

Location

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Legacy Research Institute

Portland, Oregon, 97210, United States

Location

Adler Institute for Advanced Imaging

Jenkintown, Pennsylvania, 19046, United States

Location

Pearl Clinical Research

Norristown, Pennsylvania, 19401, United States

Location

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Heights Doctors Clinic

Houston, Texas, 77008, United States

Location

Yvonne Kew MD PLLC Neuro-Oncology Clinic

Houston, Texas, 77030, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

The Clinical Research Group, Inc.

Lewisville, Texas, 76117, United States

Location

Texas Medical Research Associates, LLC

San Antonio, Texas, 78238, United States

Location

National Clinical Research-Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Dean Foundation for Health, Research and Education, Inc.

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognition Disorders

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 29, 2016
• Study Start: October 1, 2016
• Primary Completion: October 18, 2017
• Study Completion: October 18, 2017
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (75)