Clinical trial NCT02918539: Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
Official title: Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Cognition Disorders
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
name: PRA Health Sciences
First posted: 2016-09-29
Enrollment: 317
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

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