Alzheimer DiseaseRAmPNCT02918539
Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
An observational study of Alzheimer Disease and Cognition Disorders, run by Avid Radiopharmaceuticals at 75 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Cognition Disorders
- What is being tested?
- florbetapir F 18 PET scan
- Type of treatment
- Injection or infusion
- How many people
- 317 participants
- Where
- 75 sitesUnited States
- Study dates
- Oct 2016to 18 Oct 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
75 sites in 1 country.
75 sites in 1 country
United States75 sites
Community Hospital of Anderson and Madison Country
Anderson, Indiana, 46011
Doctors Clinical Research
Atlanta, Georgia, 30312
JEM Research Institute
Atlantis, Florida, 33462
American Health Network of Indiana
Avon, Indiana, 46123
Sheppard Pratt Health System
Baltimore, Maryland, 21204
Spectrum Clinical Research
Baltimore, Maryland, 21228
Boston Center for Memory
Brookline, Massachusetts, 02467
Integrative Clinical Trials
Brooklyn, New York, 11229
Ptak Alzheimer Research Center
Clearwater, Florida, 33756
Wisdom Clinical Research Institute
Coral Gables, Florida, 33134
Millenium Psychiatric Associates
Creve Coeur, Missouri, 63141
Dayton Center for Neurological Disorders
Dayton, Ohio, 45429
iResearch Atlanta
Decatur, Georgia, 30030
Mile High Research Center
Denver, Colorado, 80218
Clinical Inquest Center
Dublin, Ohio, 43017
Michigan State University
East Lansing, Michigan, 48824
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914
American Health Network of Indiana, LLC
Franklin, Indiana, 46131
Neurology Center of North Orange County
Fullerton, California, 92835
Arrowhead Internal Medicine, PC
Glendale, Arizona, 85381
Adirondack Medical Research
Glens Falls, New York, 12801
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Direct Helpers Research
Hialeah, Florida, 33012
Healing Touch C&C Research Inc
Hialeah, Florida, 33012
Galiz Research
Hialeah, Florida, 33016
Advanced Research Institute of Miami
Homestead, Florida, 33030
Heights Doctors Clinic
Houston, Texas, 77008
Yvonne Kew MD PLLC Neuro-Oncology Clinic
Houston, Texas, 77030
Irvine Center for Clinical Research
Irvine, California, 92614
Adler Institute for Advanced Imaging
Jenkintown, Pennsylvania, 19046
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653
Neurological Associates of Long Island
Lake Success, New York, 11042
FMC Science
Lampasas, Texas, 76550
Las Vegas Medical Center
Las Vegas, Nevada, 89113
Precision Clinical Research
Lauderdale Lakes, Florida, 33319
The Clinical Research Group, Inc.
Lewisville, Texas, 76117
Neurology Associates, PA
Maitland, Florida, 32751
Amici Clinical Research
Martinsville, New Jersey, 08836
Merritt Island Medical Research
Merritt Island, Florida, 32952
Homestead Associates in Research
Miami, Florida, 33032
Dade Research Center
Miami, Florida, 33135
United Clinical Research, Corp.
Miami, Florida, 33155
Advanced Medical Research Institute (AMRI)
Miami, Florida, 33174
New Horizon Research Center
Miami, Florida, 33175
Advance Research Development Solutions
Miami Lakes, Florida, 33014
Dean Foundation for Health, Research and Education, Inc.
Middleton, Wisconsin, 53562
Coastal Conneticut Research
New London, Connecticut, 06320
Pearl Clinical Research
Norristown, Pennsylvania, 19401
Bravo Health Care Center
North Bay Village, Florida, 33141
Laszlo J. Mate, MD
North Palm Beach, Florida, 33408
Pines Care Research Center
Pembroke Pines, Florida, 33026
Center for Neuro and Spine Inc. (CNS) - Main Office
Phoenix, Arizona, 85032
Neurostudies.net, LLC
Port Charlotte, Florida, 33952
Progressive Medical Research
Port Orange, Florida, 32127
Legacy Research Institute
Portland, Oregon, 97210
National Clinical Research-Richmond, Inc.
Richmond, Virginia, 23294
Woodland Research Northwest
Rogers, Arkansas, 72758
Texas Medical Research Associates, LLC
San Antonio, Texas, 78238
Pacific Research Network
San Diego, California, 92103
Syrentis Clinical Research
Santa Ana, California, 92705
Imaging Endpoints
Scottsdale, Arizona, 85258
North Bay Neuroscience Institute
Sebastopol, California, 95472
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07801
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713
Richmond Behavioral Associates
Staten Island, New York, 10312
Center for Neurology and Spine
Sun City, Arizona, 85351
Olympian Clinical Research - South Tampa Office
Tampa, Florida, 33609
Tampa Neurology Associates
Tampa, Florida, 33609
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, 08755
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104
Lovelance Scientific Resources, Inc.
Venice, Florida, 34292
Neurology Specialists of Monmouth County, PA
West Long Branch, New Jersey, 07764
Sand Lake Imaging, MRI Facility
Winter Park, Florida, 32789
About this study
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.
- Conditions
- Alzheimer Disease, Cognition Disorders
- Being tested
- florbetapir F 18 PET scan
- Medical subject headings
- Alzheimer Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
florbetapir F 18 PET scanDrug
Also called Amyvid
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: florbetapir F 18 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company, PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918539
- Sponsor's protocol ID
- 18F-AV-45-A25
- Other IDs
- PRA Study Code: 446601
- Acronym
- RAmP
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2016
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Amyloid Positive Patients for Alzheimer's Disease Drug Research Trials
- ClinicalTrials.gov ID
- NCT02918539
- Acronym / sponsor ID
- RAmP / 18F-AV-45-A25
- Conditions
- Alzheimer Disease, Cognition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company, PRA Health Sciences
- Study start
- Oct 2016
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAmP Registry Patients | – | Drug: florbetapir F 18 PET scanPatients 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| florbetapir F 18 PET scanAlso: AmyvidFor 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 | Drug | RAmP Registry Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study chair
Avid Radiopharmaceuticals
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Cognition Disorders, run by Avid Radiopharmaceuticals at 75 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Registry Participation (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.