Clincosm LogoSign in Get a demo

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

Sponsor
Avid Radiopharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02918539
Collaborator
Eli Lilly and Company (Industry), PRA Health Sciences (Industry)
317
Enrollment
75
Locations
12.6
Duration (Months)
4.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: florbetapir F 18 PET scan

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
317 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Oct 18, 2017
Actual Study Completion Date :
Oct 18, 2017

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Amyvid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Arrowhead Internal Medicine, PC Glendale Arizona United States 85381
    2 Center for Neuro and Spine Inc. (CNS) - Main Office Phoenix Arizona United States 85032
    3 Imaging Endpoints Scottsdale Arizona United States 85258
    4 Center for Neurology and Spine Sun City Arizona United States 85351
    5 Woodland Research Northwest Rogers Arkansas United States 72758
    6 Neurology Center of North Orange County Fullerton California United States 92835
    7 Irvine Center for Clinical Research Irvine California United States 92614
    8 Senior Clinical Trials, Inc. Laguna Hills California United States 92653
    9 Pacific Research Network San Diego California United States 92103
    10 Syrentis Clinical Research Santa Ana California United States 92705
    11 North Bay Neuroscience Institute Sebastopol California United States 95472
    12 Mile High Research Center Denver Colorado United States 80218
    13 Coastal Conneticut Research New London Connecticut United States 06320
    14 JEM Research Institute Atlantis Florida United States 33462
    15 Ptak Alzheimer Research Center Clearwater Florida United States 33756
    16 Wisdom Clinical Research Institute Coral Gables Florida United States 33134
    17 Direct Helpers Research Hialeah Florida United States 33012
    18 Healing Touch C&C Research Inc Hialeah Florida United States 33012
    19 Galiz Research Hialeah Florida United States 33016
    20 Advanced Research Institute of Miami Homestead Florida United States 33030
    21 Precision Clinical Research Lauderdale Lakes Florida United States 33319
    22 Neurology Associates, PA Maitland Florida United States 32751
    23 Merritt Island Medical Research Merritt Island Florida United States 32952
    24 Advance Research Development Solutions Miami Lakes Florida United States 33014
    25 Homestead Associates in Research Miami Florida United States 33032
    26 Dade Research Center Miami Florida United States 33135
    27 United Clinical Research, Corp. Miami Florida United States 33155
    28 Advanced Medical Research Institute (AMRI) Miami Florida United States 33174
    29 New Horizon Research Center Miami Florida United States 33175
    30 Bravo Health Care Center North Bay Village Florida United States 33141
    31 Laszlo J. Mate, MD North Palm Beach Florida United States 33408
    32 Pines Care Research Center Pembroke Pines Florida United States 33026
    33 Neurostudies.net, LLC Port Charlotte Florida United States 33952
    34 Progressive Medical Research Port Orange Florida United States 32127
    35 Suncoast Neuroscience Associates, Inc. Saint Petersburg Florida United States 33713
    36 Olympian Clinical Research - South Tampa Office Tampa Florida United States 33609
    37 Tampa Neurology Associates Tampa Florida United States 33609
    38 University of South Florida Health Byrd Alzheimer's Institute Tampa Florida United States 33613
    39 Lovelance Scientific Resources, Inc. Venice Florida United States 34292
    40 Sand Lake Imaging, MRI Facility Winter Park Florida United States 32789
    41 Doctors Clinical Research Atlanta Georgia United States 30312
    42 iResearch Atlanta Decatur Georgia United States 30030
    43 Community Hospital of Anderson and Madison Country Anderson Indiana United States 46011
    44 American Health Network of Indiana Avon Indiana United States 46123
    45 American Health Network of Indiana, LLC Franklin Indiana United States 46131
    46 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
    47 Sheppard Pratt Health System Baltimore Maryland United States 21204
    48 Spectrum Clinical Research Baltimore Maryland United States 21228
    49 Boston Center for Memory Brookline Massachusetts United States 02467
    50 Michigan State University East Lansing Michigan United States 48824
    51 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    52 Millenium Psychiatric Associates Creve Coeur Missouri United States 63141
    53 Las Vegas Medical Center Las Vegas Nevada United States 89113
    54 Amici Clinical Research Martinsville New Jersey United States 08836
    55 The Cognitive and Research Center of New Jersey Springfield New Jersey United States 07801
    56 Advanced Memory Research Institute of NJ, PC Toms River New Jersey United States 08755
    57 Neurology Specialists of Monmouth County, PA West Long Branch New Jersey United States 07764
    58 Integrative Clinical Trials Brooklyn New York United States 11229
    59 Adirondack Medical Research Glens Falls New York United States 12801
    60 Neurological Associates of Long Island Lake Success New York United States 11042
    61 Richmond Behavioral Associates Staten Island New York United States 10312
    62 Dayton Center for Neurological Disorders Dayton Ohio United States 45429
    63 Clinical Inquest Center Dublin Ohio United States 43017
    64 Tulsa Clinical Research, LLC Tulsa Oklahoma United States 74104
    65 Legacy Research Institute Portland Oregon United States 97210
    66 Adler Institute for Advanced Imaging Jenkintown Pennsylvania United States 19046
    67 Pearl Clinical Research Norristown Pennsylvania United States 19401
    68 Rhode Island Mood and Memory Research Institute East Providence Rhode Island United States 02914
    69 Heights Doctors Clinic Houston Texas United States 77008
    70 Yvonne Kew MD PLLC Neuro-Oncology Clinic Houston Texas United States 77030
    71 FMC Science Lampasas Texas United States 76550
    72 The Clinical Research Group, Inc. Lewisville Texas United States 76117
    73 Texas Medical Research Associates, LLC San Antonio Texas United States 78238
    74 National Clinical Research-Richmond, Inc. Richmond Virginia United States 23294
    75 Dean Foundation for Health, Research and Education, Inc. Middleton Wisconsin United States 53562

    Sponsors and Collaborators

    • Avid Radiopharmaceuticals
    • Eli Lilly and Company
    • PRA Health Sciences

    Investigators

    • Study Chair: Chief Medical Officer, Avid Radiopharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Avid Radiopharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02918539
    Other Study ID Numbers:
    • 18F-AV-45-A25
    • PRA Study Code: 446601
    First Posted:
    Sep 29, 2016
    Last Update Posted:
    Oct 24, 2018
    Last Verified:
    Oct 1, 2018
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognition Disorders

    Study Results

    No Results Posted as of Oct 24, 2018