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

NCT ID: NCT02918539

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-10-18

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease Cognition Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

florbetapir F 18 PET scan

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Amyvid

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

PRA Health Sciences

INDUSTRY

Sponsor Role collaborator

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chief Medical Officer

Role: STUDY_CHAIR

Avid Radiopharmaceuticals, Inc.

Locations

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Arrowhead Internal Medicine, PC

Glendale, Arizona, United States

Site Status

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

Phoenix, Arizona, United States

Site Status

Imaging Endpoints

Scottsdale, Arizona, United States

Site Status

Center for Neurology and Spine

Sun City, Arizona, United States

Site Status

Woodland Research Northwest

Rogers, Arkansas, United States

Site Status

Neurology Center of North Orange County

Fullerton, California, United States

Site Status

Irvine Center for Clinical Research

Irvine, California, United States

Site Status

Senior Clinical Trials, Inc.

Laguna Hills, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

North Bay Neuroscience Institute

Sebastopol, California, United States

Site Status

Mile High Research Center

Denver, Colorado, United States

Site Status

Coastal Conneticut Research

New London, Connecticut, United States

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

Ptak Alzheimer Research Center

Clearwater, Florida, United States

Site Status

Wisdom Clinical Research Institute

Coral Gables, Florida, United States

Site Status

Direct Helpers Research

Hialeah, Florida, United States

Site Status

Healing Touch C&C Research Inc

Hialeah, Florida, United States

Site Status

Galiz Research

Hialeah, Florida, United States

Site Status

Advanced Research Institute of Miami

Homestead, Florida, United States

Site Status

Precision Clinical Research

Lauderdale Lakes, Florida, United States

Site Status

Neurology Associates, PA

Maitland, Florida, United States

Site Status

Merritt Island Medical Research

Merritt Island, Florida, United States

Site Status

Homestead Associates in Research

Miami, Florida, United States

Site Status

Dade Research Center

Miami, Florida, United States

Site Status

United Clinical Research, Corp.

Miami, Florida, United States

Site Status

Advanced Medical Research Institute (AMRI)

Miami, Florida, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

Advance Research Development Solutions

Miami Lakes, Florida, United States

Site Status

Bravo Health Care Center

North Bay Village, Florida, United States

Site Status

Laszlo J. Mate, MD

North Palm Beach, Florida, United States

Site Status

Pines Care Research Center

Pembroke Pines, Florida, United States

Site Status

Neurostudies.net, LLC

Port Charlotte, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, United States

Site Status

Olympian Clinical Research - South Tampa Office

Tampa, Florida, United States

Site Status

Tampa Neurology Associates

Tampa, Florida, United States

Site Status

University of South Florida Health Byrd Alzheimer's Institute

Tampa, Florida, United States

Site Status

Lovelance Scientific Resources, Inc.

Venice, Florida, United States

Site Status

Sand Lake Imaging, MRI Facility

Winter Park, Florida, United States

Site Status

Doctors Clinical Research

Atlanta, Georgia, United States

Site Status

iResearch Atlanta

Decatur, Georgia, United States

Site Status

Community Hospital of Anderson and Madison Country

Anderson, Indiana, United States

Site Status

American Health Network of Indiana

Avon, Indiana, United States

Site Status

American Health Network of Indiana, LLC

Franklin, Indiana, United States

Site Status

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Site Status

Sheppard Pratt Health System

Baltimore, Maryland, United States

Site Status

Spectrum Clinical Research

Baltimore, Maryland, United States

Site Status

Boston Center for Memory

Brookline, Massachusetts, United States

Site Status

Michigan State University

East Lansing, Michigan, United States

Site Status

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

Millenium Psychiatric Associates

Creve Coeur, Missouri, United States

Site Status

Las Vegas Medical Center

Las Vegas, Nevada, United States

Site Status

Amici Clinical Research

Martinsville, New Jersey, United States

Site Status

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

Site Status

Advanced Memory Research Institute of NJ, PC

Toms River, New Jersey, United States

Site Status

Neurology Specialists of Monmouth County, PA

West Long Branch, New Jersey, United States

Site Status

Integrative Clinical Trials

Brooklyn, New York, United States

Site Status

Adirondack Medical Research

Glens Falls, New York, United States

Site Status

Neurological Associates of Long Island

Lake Success, New York, United States

Site Status

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

Dayton Center for Neurological Disorders

Dayton, Ohio, United States

Site Status

Clinical Inquest Center

Dublin, Ohio, United States

Site Status

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, United States

Site Status

Legacy Research Institute

Portland, Oregon, United States

Site Status

Adler Institute for Advanced Imaging

Jenkintown, Pennsylvania, United States

Site Status

Pearl Clinical Research

Norristown, Pennsylvania, United States

Site Status

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, United States

Site Status

Heights Doctors Clinic

Houston, Texas, United States

Site Status

Yvonne Kew MD PLLC Neuro-Oncology Clinic

Houston, Texas, United States

Site Status

FMC Science

Lampasas, Texas, United States

Site Status

The Clinical Research Group, Inc.

Lewisville, Texas, United States

Site Status

Texas Medical Research Associates, LLC

San Antonio, Texas, United States

Site Status

National Clinical Research-Richmond, Inc.

Richmond, Virginia, United States

Site Status

Dean Foundation for Health, Research and Education, Inc.

Middleton, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRA Study Code: 446601

Identifier Type: OTHER

Identifier Source: secondary_id

18F-AV-45-A25

Identifier Type: -

Identifier Source: org_study_id

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