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

Study Overview
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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.

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

Conditions
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Alzheimer Disease, Cognition Disorders

Intervention / Treatment
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* Drug: florbetapir F 18 PET scan


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RAmP Registry Patients<br>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 | Drug: florbetapir F 18 PET scan<br>* 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<br>* Other names: Amyvid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Registry Participation | 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. | Two years |