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

Completed

• Conditions: Alzheimer Disease; Cognition Disorders
• Interventions: Drug: florbetapir F 18 PET scan

• Registration Number: NCT02918539
• Lead Sponsor: Avid Radiopharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Study Start: 2016-10
• Primary Completion: 2017-10-18
• Study Completion: 2017-10-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RAmP Registry Patients	florbetapir F 18 PET scan	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

Primary Outcome Measures

Name	Time	Method
Patient Registry Participation	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.

Trial Locations

Locations (75)

Arrowhead Internal Medicine, PC; 🇺🇸 Glendale, Arizona, United States

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

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