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NCT04437511Active, not recruitingPhase 3

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1736 (actual)
First submitted
17 Jun 2020
Start date
19 Jun 2020
Primary completion date
14 Apr 2023
Lead sponsor
Eli Lilly and Company
NCT number
NCT04437511
EU CT number
2023-507303-55-00
EudraCT number
2020-000077-25

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1736
  • From 19 Jun 2020 to the primary completion date, 14 Apr 2023
  • 269 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current treatment with immunoglobulin G (IgG) therapy

Other

  • Contraindication to MRI or PET scans

Who the study is looking for

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
  • MMSE score of 20 to 28 (inclusive) at baseline
  • Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
  • Meet 18F florbetapir PET scan (central read) criteria
  • Have a study partner who will provide written informed consent to participate

Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (269)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NeuroCentrix
Coordinator of this site? Confirm its status
CarltonAustraliaUnknown status
Central Coast Neurosciences Research
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ErinaAustraliaUnknown status
Delmont Private Hospital
Coordinator of this site? Confirm its status
Glen IrisAustraliaUnknown status
HammondCare
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MalvernAustraliaUnknown status
The Alfred Hospital
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MelbourneAustraliaUnknown status
The Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
St Vincent's Hospital
Coordinator of this site? Confirm its status
SydneyAustraliaUnknown status
KARA Institute for Neurological Diseases
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SydneyAustraliaUnknown status
HammondCare Greenwich Hospital
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SydneyAustraliaUnknown status
Clinique de la Mémoire de l'Outaouais
Coordinator of this site? Confirm its status
GatineauCanadaUnknown status
MoCA Research and Innovation Inc.
Coordinator of this site? Confirm its status
Greenfield ParkCanadaUnknown status
True North Clinical Research
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HalifaxCanadaUnknown status
OCT Research ULC
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KelownaCanadaUnknown status
SKDS Research Inc.
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NewmarketCanadaUnknown status
True North Clinical Research
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New MinasCanadaUnknown status
Ottawa Memory Clinic
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Bruyère Research Institute
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OttawaCanadaUnknown status
Kawartha Centre - Redefining Healthy Aging
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PeterboroughCanadaUnknown status
Alpha Recherche Clinique
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QuébecCanadaUnknown status
Bluewater Clinical Research Group Inc.
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SarniaCanadaUnknown status
Q&T Research Sherbrooke Inc.
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SherbrookeCanadaUnknown status
Diex Recherche Sherbrooke Inc.
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SherbrookeCanadaUnknown status
Baycrest Health Sciences
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TorontoCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Toronto Memory Program
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TorontoCanadaUnknown status
A-Shine s.r.o.
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Plzen 3CzechiaCompleted
Fakultní nemocnice v Motole
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-CzechiaCompleted
Ústřední vojenská fakultní nemocnice
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-CzechiaCompleted
Re:Cognition Health - Birmingham
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BirminghamUnited KingdomUnknown status
Re:Cognition Health - Guildford
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GuildfordUnited KingdomUnknown status
Re:Cognition Health - London
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LondonUnited KingdomUnknown status
Glasgow Memory Clinic
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MotherwellUnited KingdomUnknown status
Matsui e-clinic
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AkashiJapanUnknown status
Medical Corporation Chiseikai Tokyo Center Clinic
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Chuo-kuJapanUnknown status
Moriyama Neuro Center Hospital
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Edogawa-kuJapanUnknown status
P-One Clinic
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HachiōjiJapanUnknown status
Himeji Central Hospital Affiliated Clinic
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HimejiJapanUnknown status
Hiroshima Neurology Clinic
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HiroshimaJapanUnknown status
Honmachi Clinic
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IkedaJapanUnknown status
Inage Neurology and Memory Clinic
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InageJapanUnknown status
Tokyo Medical University Ibaraki Medical Center
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InashikiJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
Kakigi Dementia Happiness Clinic
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KobeJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
KATAYAMA medical Clinic
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KurashikiJapanUnknown status
National Hospital Organization Utano National Hospital
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KyotoJapanUnknown status
Koseikai Takeda Hospital
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KyotoJapanUnknown status
Ishikawa Clinic
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KyotoJapanUnknown status
Nagoya Ekisaikai Hospital
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NagoyaJapanUnknown status
Kojunkai Daido Clinic
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NagoyaJapanUnknown status
Chubu Rosai Hospital
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NagoyaJapanUnknown status
National Center for Geriatrics and Gerontology
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ŌbuJapanUnknown status
Oita Prefectural Hospital
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ŌitaJapanUnknown status
Clinical Research Hospital Tokyo
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Shinjuku-kuJapanUnknown status
Tokyo Metro Bokutoh Hospital
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Sumida-kuJapanUnknown status
Takatsuki General Hospital
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TakatsukiJapanUnknown status
Itsuki Hospital
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TokushimaJapanUnknown status
Nippon Medical School Hospital
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TokyoJapanUnknown status
Tokyo Asbo Clinic
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TokyoJapanUnknown status
Makita General Hospital
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TokyoJapanUnknown status
Memory Clinic Toride
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TorideJapanUnknown status
Yokohama City Minato Red Cross Hospital
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YokohamaJapanUnknown status
Oita University Hospital
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YufuJapanUnknown status
Brain Research Center Amsterdam B.V.
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AmsterdamNetherlandsCompleted
Brain Research Center Den Bosch B.V.
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's-HertogenboschNetherlandsCompleted
Brain Research Center Zwolle B.V.
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ZwolleNetherlandsCompleted
Klimed MK Sp. z o.o.
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BialystokPolandCompleted
Podlaskie Centrum Psychogeriatrii
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Bia?ystokPolandCompleted
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandCompleted
Diamond Clinic Sp. z o.o.
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CracowPolandCompleted
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Clinirem Sp. z o.o.
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LublinPolandCompleted
Ilkowski I Partnerzy sp.p. Lekarzy
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PoznanPolandCompleted
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych Im. Ksiedza Henryka Kardynala Gulbinowicza Osrodek Alzheimerowski Sp. z o.o.
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ScinawaPolandCompleted
Neuro-Care Sp. z o.o. sp.k.
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Siemianowice SlaskiePolandCompleted
Centrum Medyczne SENIOR
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SopotPolandCompleted
EUROMEDIS Sp z o o
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SzczecinPolandCompleted
Futuremeds Sp. z o.o.
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WarsawPolandCompleted
Centrum Medyczne NeuroProtect
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WarsawPolandCompleted
Wrocławskie Centrum Alzheimerowskie (WCA)
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WroclawPolandCompleted
SCB Research Center
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BayamónPuerto RicoUnknown status
Instituto De Neurologia Dra. Ivonne Fraga
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San JuanPuerto RicoUnknown status
Barbara Diaz Hernandez MD Research Inc
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San JuanPuerto RicoUnknown status
INSPIRA Clinical Research
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San JuanPuerto RicoUnknown status
Abington Neurological Associates, Ltd
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AbingtonUnited StatesUnknown status
Albany Medical College
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AlbanyUnited StatesUnknown status
Neurological Associates Albany
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AlbanyUnited StatesUnknown status
McFarland Clinic, PC
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AmesUnited StatesUnknown status
Dent Neurologic Institute
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AmherstUnited StatesUnknown status
Integrated Neurology Services - Falls Church
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ArlingtonUnited StatesUnknown status
JEM Research Institute
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AtlantisUnited StatesUnknown status
Senior Adults Specialty Research
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AustinUnited StatesUnknown status
VIN-Julie Schwartzbard
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AventuraUnited StatesUnknown status
Mountain Neurological Research Center
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BasaltUnited StatesUnknown status
Gadolin Research
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BeaumontUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
The Memory Clinic
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BenningtonUnited StatesUnknown status
Neurology Offices of South Florida
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Boca RatonUnited StatesUnknown status
SFM Clinical Research
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Boca RatonUnited StatesUnknown status
Northwest Clinical Trials
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BoiseUnited StatesUnknown status
Citizens Memorial Hospital District
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BolivarUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Alpine Clinical Research Center
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BoulderUnited StatesUnknown status
University at Buffalo - UBMD Neurology
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BuffaloUnited StatesUnknown status
Gwinnett Research Institute
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BufordUnited StatesUnknown status
NeuroScience Research Center
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CantonUnited StatesUnknown status
North County Neurology Associates
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CarlsbadUnited StatesUnknown status
Valley Medical Research
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CentervilleUnited StatesUnknown status
CHS-Behavioral Health Research
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CharlotteUnited StatesUnknown status
Clinical Research Professionals
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ChesterfieldUnited StatesUnknown status
Great Lakes Clinical Trials - Andersonville
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ChicagoUnited StatesUnknown status
Rapid Medical Research
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ClevelandUnited StatesUnknown status
Colorado Springs Neurological Associates
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Colorado SpringsUnited StatesUnknown status
Prism Health Richland Department of Neurology Research
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ColumbiaUnited StatesUnknown status
Ohio State University
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ColumbusUnited StatesUnknown status
Columbus Memory Center, LLC
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ColumbusUnited StatesUnknown status
Neurology Clinic, P.C.
Coordinator of this site? Confirm its status
CordovaUnited StatesUnknown status
Kerwin Medical Center
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DallasUnited StatesUnknown status
Neurology Consultants of Dallas, PA
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DallasUnited StatesUnknown status
Neurology Diagnostics, Inc.
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DaytonUnited StatesUnknown status
University of Cincinnati Physicians Company, LLC
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DaytonUnited StatesUnknown status
NeuroStudies
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DecaturUnited StatesUnknown status
Brain Matters Research
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Delray BeachUnited StatesUnknown status
Cohen Medical Associates
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Delray BeachUnited StatesUnknown status
Colorado Neurological Research Center, PC
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DenverUnited StatesUnknown status
InSite Clinical Research
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DeSotoUnited StatesUnknown status
Integrity Clinical Research
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DoralUnited StatesUnknown status
Rhode Island Mood & Memory Research Institute
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East ProvidenceUnited StatesUnknown status
Clarity Clinical Research
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East SyracuseUnited StatesUnknown status
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
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Elk Grove VillageUnited StatesUnknown status
Wr- Pri, Llc
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EncinoUnited StatesUnknown status
The University of Kansas - Clinical Research Center
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FairwayUnited StatesUnknown status
NECCR PrimaCare Research
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Fall RiverUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Health Initiatives Research
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FayettevilleUnited StatesUnknown status
Precise Research Centers
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FlowoodUnited StatesUnknown status
Neuropsychiatric Research Center of Southwest Florida
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Fort MyersUnited StatesUnknown status
Neuro-Pain Medical Center
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FresnoUnited StatesUnknown status
Neurology Center of North Orange County
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FullertonUnited StatesUnknown status
Center for Advanced Research & Education
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GainesvilleUnited StatesUnknown status
Gilbert Neurology
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GilbertUnited StatesUnknown status
Finlay Medical Research
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Greenacres CityUnited StatesUnknown status
Guilford Neurologic Associates, Inc
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GreensboroUnited StatesUnknown status
MD Clinical
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HallandaleUnited StatesUnknown status
AGA Clinical Trials
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HialeahUnited StatesUnknown status
Indago Research & Health Center, Inc
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HialeahUnited StatesUnknown status
Infinity Clinical Research, LLC
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HollywoodUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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HoustonUnited StatesUnknown status
Josephson Wallack Munshower Neurology, PC
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IndianapolisUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Irvine Clinical Research
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IrvineUnited StatesUnknown status
Encore Research Group- Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesUnknown status
EvergreenHealth Medical Center
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KirklandUnited StatesUnknown status
Senior Clinical Trials, Inc.
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Laguna HillsUnited StatesUnknown status
Kaizen Brain Center
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La JollaUnited StatesUnknown status
Accel Research Sites - Lakeland Clinical Research Unit
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LakelandUnited StatesUnknown status
Las Vegas Medical Research
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Las VegasUnited StatesUnknown status
Collaborative Neuroscience Research, LLC
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Los AlamitosUnited StatesUnknown status
USC Keck School of Medicine
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Los AngelesUnited StatesUnknown status
Clinical Research Institute
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Los AngelesUnited StatesUnknown status
ClinCloud - Maitland
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MaitlandUnited StatesUnknown status
AMC Research
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MatthewsUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
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MemphisUnited StatesUnknown status
Merritt Island Medical Research, LLC
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Merritt IslandUnited StatesUnknown status
Optimus U Corporation
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MiamiUnited StatesUnknown status
Miami Dade Medical Research Institute, LLC
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MiamiUnited StatesUnknown status
Florida International Research Center
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MiamiUnited StatesUnknown status
Miami Jewish Health
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MiamiUnited StatesUnknown status
Ezy Medical Research
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MiamiUnited StatesUnknown status
Future Care Solution
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MiamiUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
Allied Biomedical Research Institute
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MiamiUnited StatesUnknown status
The Neurology Research Group
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MiamiUnited StatesUnknown status
Finlay Medical Research
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MiamiUnited StatesUnknown status
VIN-Victor Faradji
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MiamiUnited StatesUnknown status
Homestead Associates in Research
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MiamiUnited StatesUnknown status
Mount Sinai Cancer Center
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Miami BeachUnited StatesUnknown status
Goji Group - Research Trials Group
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Miami LakesUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Neurovations
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NapaUnited StatesUnknown status
Collier Neurologic Specialists
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NaplesUnited StatesUnknown status
BTC Network
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New BedfordUnited StatesUnknown status
Institute for Neurodegenerative Disorders
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New HavenUnited StatesUnknown status
Yale University, Alzheimer's Disease Research Unit
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New HavenUnited StatesUnknown status
Hoag Memorial Hospital Presbyterian
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Newport BeachUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesUnknown status
Boston Center for Memory
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NewtonUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
Sentara Norfolk General Hospital
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NorfolkUnited StatesUnknown status
North Kansas City Hospital
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North Kansas CityUnited StatesUnknown status
Research Center for Clinical Studies
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NorwalkUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Sensible Healthcare, LLC
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OcoeeUnited StatesUnknown status
IPS Research Company
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Oklahoma CityUnited StatesUnknown status
Lynn Health Science Institute
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Oklahoma CityUnited StatesUnknown status
Medical Research Group of Central Florida
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Orange CityUnited StatesUnknown status
Synexus Clinical Research US, Inc.
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OrlandoUnited StatesUnknown status
Headlands Research Orlando
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OrlandoUnited StatesUnknown status
College Park Family Care Center/Multi Specialty Clinical Res
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Overland ParkUnited StatesUnknown status
Sharlin Health and Neurology
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OzarkUnited StatesUnknown status
IMIC, Inc.
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Palmetto BayUnited StatesUnknown status
Stanford Neuroscience Health Center
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Palo AltoUnited StatesUnknown status
Advocate Medical Group
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Park RidgeUnited StatesUnknown status
SC3 Research - Pasadena
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PasadenaUnited StatesUnknown status
Emerald Coast Neurology - Airport Boulevard
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PensacolaUnited StatesUnknown status
Penn Medicine: University of Pennsylvania Health System
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PhiladelphiaUnited StatesUnknown status
Xenoscience
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PhoenixUnited StatesUnknown status
Banner Alzheimer's Institute
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PhoenixUnited StatesUnknown status
Donald S.Marks, M.D.,P.C.
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PlymouthUnited StatesUnknown status
Keystone Clinical Studies
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Plymouth MeetingUnited StatesUnknown status
Quantum Laboratories Clinical Research
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Pompano BeachUnited StatesUnknown status
Center for Cognitive Health
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PortlandUnited StatesUnknown status
Summit Headlands
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PortlandUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
PCND Neurology
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PowayUnited StatesUnknown status
Alzheimers Disease Center
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QuincyUnited StatesUnknown status
Anderson Clinical Research
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RedlandsUnited StatesUnknown status
National Clinical Research, Inc
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RichmondUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
Central Texas Neurology Consultants
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Round RockUnited StatesUnknown status
Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases
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San AntonioUnited StatesUnknown status
Artemis Institute for Clinical Research
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San DiegoUnited StatesUnknown status
Pacific Research Network
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San DiegoUnited StatesUnknown status
Sharp Neurocognitive Research Center
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San DiegoUnited StatesUnknown status
UCSF Memory and Aging Center
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San FranciscoUnited StatesUnknown status
Syrentis Clinical Research
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Santa AnaUnited StatesUnknown status
Roskamp Institute Clinical Trials Division
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SarasotaUnited StatesUnknown status
Intercoastal Medical Group
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SarasotaUnited StatesUnknown status
Maine Medical Center-Maine Medical Partners Neurology
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ScarboroughUnited StatesUnknown status
Perseverance Research Center
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ScottsdaleUnited StatesUnknown status
University of Washington - Harborview Medical Center
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SeattleUnited StatesUnknown status
California Neuroscience Research Medical Group, Inc.
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Sherman OaksUnited StatesUnknown status
Kingfisher Cooperative
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SpokaneUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
The Cognitive and Research Center of New Jersey
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SpringfieldUnited StatesUnknown status
Ki Health Partners, LLc, dba New England Institute for Clinical Research
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StamfordUnited StatesUnknown status
Richmond Behavioral Associates
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Staten IslandUnited StatesUnknown status
Arch Clinical Trials
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St LouisUnited StatesUnknown status
Suncoast Neuroscience Associates, Inc.
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St. PetersburgUnited StatesUnknown status
Brain Matters Research
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StuartUnited StatesUnknown status
Alzheimer's Research and Treatment Center
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StuartUnited StatesUnknown status
Banner Sun Health Research Institute
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Sun CityUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
Universal Research Group
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TacomaUnited StatesUnknown status
Tallahassee Neurological Clinic
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TallahasseeUnited StatesUnknown status
Stedman Clinical Trials
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TampaUnited StatesUnknown status
USF Health Byrd Alzheimer's Institute
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TampaUnited StatesUnknown status
Axiom Clinical Research of Florida
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TampaUnited StatesUnknown status
Charter Research - Lady Lake
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The VillagesUnited StatesUnknown status
Synexus Clinical Research US, Inc.
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The VillagesUnited StatesUnknown status
Bio Behavioral Health
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Toms RiverUnited StatesUnknown status
Advanced Memory Research Institute of New Jersey
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Toms RiverUnited StatesUnknown status
Cotton O'Neil Clinical Research Center - Central Office
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TopekaUnited StatesUnknown status
Banner Alzheimer's Institute Tucson
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TucsonUnited StatesUnknown status
Center for Neurosciences
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TucsonUnited StatesUnknown status
Central States Research
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TulsaUnited StatesUnknown status
Tilda Research
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TustinUnited StatesUnknown status
MedVadis Research Corporation
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WalthamUnited StatesUnknown status
Georgetown University Medical Center
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Washington D.C.United StatesUnknown status
Covenant Medical Center
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WaterlooUnited StatesUnknown status
Adams Clinical
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WatertownUnited StatesUnknown status
Alzheimer's Research and Treatment Center
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WellingtonUnited StatesUnknown status
Palm Beach Neurology
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West Palm BeachUnited StatesUnknown status
Ascension via Christi Research
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WichitaUnited StatesUnknown status
Accellacare - Winston-Salem
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Winston-SalemUnited StatesUnknown status
Conquest Research
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Winter ParkUnited StatesUnknown status
Charter Research - Winter Park
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Winter ParkUnited StatesUnknown status

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