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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02918539
First Posted: September 29, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eli Lilly and Company
PRA Health Sciences
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
  Purpose
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.

Condition Intervention
Alzheimer Disease Cognition Disorders Drug: florbetapir F 18 PET scan

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 2000
Study Start Date: October 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RAmP Registry Patients
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
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 Name: Amyvid

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918539


  Show 75 Study Locations
Sponsors and Collaborators
Avid Radiopharmaceuticals
Eli Lilly and Company
PRA Health Sciences
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
  More Information

Additional Information:
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02918539     History of Changes
Other Study ID Numbers: 18F-AV-45-A25
PRA Study Code: 446601 ( Other Identifier: PRA Health Sciences )
First Submitted: September 13, 2016
First Posted: September 29, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders