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

Completed

Conditions studied: Alzheimer Disease, Cognition Disorders

In brief

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.

Key facts

Study ID

NCT02918539

Run by

Avid Radiopharmaceuticals

People needed

317

Starts

2016-10-01

Expected to finish

2017-10-18

Last updated by the study team

2018-10-24

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Center for Neuro and Spine Inc. (CNS) - Main Office — Phoenix, Arizona, United States
• Imaging Endpoints — Scottsdale, Arizona, United States
• Center for Neurology and Spine — Sun City, Arizona, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Senior Clinical Trials, Inc. — Laguna Hills, California, United States
• Pacific Research Network — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• North Bay Neuroscience Institute — Sebastopol, California, United States
• Mile High Research Center — Denver, Colorado, United States
• Coastal Conneticut Research — New London, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Ptak Alzheimer Research Center — Clearwater, Florida, United States
• Wisdom Clinical Research Institute — Coral Gables, Florida, United States
• Direct Helpers Research — Hialeah, Florida, United States
• Healing Touch C&C Research Inc — Hialeah, Florida, United States
• Galiz Research — Hialeah, Florida, United States
• Advanced Research Institute of Miami — Homestead, Florida, United States
• Precision Clinical Research — Lauderdale Lakes, Florida, United States
• Neurology Associates, PA — Maitland, Florida, United States
• Merritt Island Medical Research — Merritt Island, Florida, United States
• Homestead Associates in Research — Miami, Florida, United States
• Dade Research Center — Miami, Florida, United States
• Arrowhead Internal Medicine, PC — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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