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OpenTrials
Completed

NCT Number: NCT02918539

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrowhead Internal Medicine, PC, Glendale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

florbetapir F 18 PET scan

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

Other names: Amyvid

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Collaborators

  • Eli Lilly and Company
  • PRA Health Sciences

Registry information

Acronym: RAmP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2016
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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