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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avid Radiopharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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