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

October 23, 2018 updated by: Avid Radiopharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Amyvid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Collaborators

Eli Lilly and Company
PRA Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 18, 2017

Study Completion (Actual)

October 18, 2017

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-45-A25
  • PRA Study Code: 446601 (Other Identifier: PRA Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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