A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04437511
Collaborator
(none)
1,800
282
2
62.1
6.4
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.
Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Actual Study Start Date
:
Jun 19, 2020
Anticipated Primary Completion Date
:
Apr 21, 2023
Anticipated Study Completion Date
:
Aug 22, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Donanemab Donanemab given intravenously (IV). |
Drug: Donanemab
Given IV
Other Names:
|
| Placebo Comparator: Placebo Placebo given IV. |
Drug: Placebo
Given IV
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [Baseline, Up to Week 76]
Change from Baseline on the iADRS in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
Secondary Outcome Measures
- Change from Baseline on the Mini Mental State Examination (MMSE) Score [Baseline, Up to Week 76]
Change from Baseline on the MMSE Score in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
- Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [Baseline, Up to Week 76]
Change from Baseline on the ADAS-Cog13 in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'
- Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [Baseline, Up to Week 76]
Change from Baseline on the CDR-SB in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
- Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score [Baseline, Up to Week 76]
Change from Baseline on the ADCS-iADL Score in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
- Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [Baseline, Up to Week 76]
Change from Baseline in Brain Amyloid Plaque Deposition as measured by Florbetapir F18 PET Scan
- Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan [Baseline, Up to Week 76]
Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
- Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI) [Baseline, Up to Week 76]
Change from Baseline in Brain Volume as Measured by vMRI
- Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab [Baseline through Week 76]
PK: Average Serum Concentration at steady state of Donanemab
- Number or Participants with Anti-Donanemab Antibodies [Baseline through Week 76]
Number or Participants with Anti-Donanemab Antibodies
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Contraindication to MRI or PET scans
-
Current treatment with immunoglobulin G (IgG) therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ARS- Neurology and Neurodiagnostics of Alabama | Hoover | Alabama | United States | 35244 |
| 2 | Gilbert Neurology | Gilbert | Arizona | United States | 85297 |
| 3 | 21st Century Neurology, a division of Xenoscience | Phoenix | Arizona | United States | 85004 |
| 4 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
| 5 | Perseverance Research Center | Scottsdale | Arizona | United States | 85254 |
| 6 | Banner Sun Health Research Institute | Sun City | Arizona | United States | 85351 |
| 7 | Banner Alzheimer's Institute | Tucson | Arizona | United States | 85718 |
| 8 | Center for Neurosciences | Tucson | Arizona | United States | 85718 |
| 9 | Health Initiatives Research | Fayetteville | Arkansas | United States | 72703 |
| 10 | North County Neurology Associates | Carlsbad | California | United States | 92011 |
| 11 | Axiom Research LLC | Colton | California | United States | 92324 |
| 12 | Pharmacology Research Institute | Encino | California | United States | 91316 |
| 13 | Neuro-Pain Medical Center | Fresno | California | United States | 93710 |
| 14 | Neurology Center of North Orange County | Fullerton | California | United States | 92835 |
| 15 | Tilda Research | Irvine | California | United States | 92612 |
| 16 | Irvine Clinical Research Center | Irvine | California | United States | 92614 |
| 17 | Kaizen Brain Center | La Jolla | California | United States | 92037 |
| 18 | Senior Clinical Trials, Inc. | Laguna Hills | California | United States | 92653 |
| 19 | Collaborative Neuroscience Research, LLC | Long Beach | California | United States | 90806 |
| 20 | USC Keck School of Medicine | Los Angeles | California | United States | 90033 |
| 21 | Clinical Research Institute LLC | Los Angeles | California | United States | 90048 |
| 22 | Neurovations | Napa | California | United States | 94558 |
| 23 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92663 |
| 24 | Stanford Neuroscience Health Center | Palo Alto | California | United States | 94304 |
| 25 | SC3 Research Group Inc Pasadena | Pasadena | California | United States | 91105 |
| 26 | PCND Neuroscience Research Institute | Poway | California | United States | 92064 |
| 27 | Anderson Clinical Research | Redlands | California | United States | 92374 |
| 28 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
| 29 | Pacific Research Network | San Diego | California | United States | 92103 |
| 30 | Sharp Mesa Vista Hospital | San Diego | California | United States | 92123 |
| 31 | Univ of California San Francisco | San Francisco | California | United States | 94158 |
| 32 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
| 33 | California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | United States | 91403 |
| 34 | Mountain Neurological Research Center | Basalt | Colorado | United States | 81621 |
| 35 | Alpine Clinical Research Center | Boulder | Colorado | United States | 80301 |
| 36 | Colorado Springs Neurological Associates | Colorado Springs | Colorado | United States | 80907 |
| 37 | Colorado Neurological Research Center, PC | Denver | Colorado | United States | 80210 |
| 38 | Institute for Neurodegenerative Disorders | New Haven | Connecticut | United States | 06510 |
| 39 | Yale University School of Medicine | New Haven | Connecticut | United States | 06510 |
| 40 | Research Center for Clinical Studies | Norwalk | Connecticut | United States | 06851 |
| 41 | New England Institute for Clinical Research | Stamford | Connecticut | United States | 06905 |
| 42 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 43 | Neurology of Central Florida Research Center | Altamonte Springs | Florida | United States | 32714 |
| 44 | JEM Research Institute | Atlantis | Florida | United States | 33462 |
| 45 | VIN-Julie Schwartzbard | Aventura | Florida | United States | 33180 |
| 46 | Neurology Offices of South Florida | Boca Raton | Florida | United States | 33428 |
| 47 | SFM Research (South Florida Neurology Associates) | Boca Raton | Florida | United States | 33487 |
| 48 | Brain Matters Research | Delray Beach | Florida | United States | 33445 |
| 49 | Cohen Medical Associates | Delray Beach | Florida | United States | 33446 |
| 50 | Integrity Clinical Research, Inc | Doral | Florida | United States | 33166 |
| 51 | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | United States | 33912 |
| 52 | Finlay Medical Research-Green Acres | Greenacres City | Florida | United States | 33467 |
| 53 | MD Clinical | Hallandale Beach | Florida | United States | 33009 |
| 54 | AGA Clinical Trials | Hialeah | Florida | United States | 33012 |
| 55 | Indago Research and Health Center Inc. | Hialeah | Florida | United States | 33012 |
| 56 | Infinity Clinical Research, LLC | Hollywood | Florida | United States | 33024 |
| 57 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 58 | Charter Research | Lady Lake | Florida | United States | 32159 |
| 59 | Accel Research- Lakeland | Lakeland | Florida | United States | 33803 |
| 60 | ClinCloud - Maitland | Maitland | Florida | United States | 32751 |
| 61 | Merritt Island Medical Research, LLC | Merritt Island | Florida | United States | 32952 |
| 62 | Mount Sinai Cancer Center | Miami Beach | Florida | United States | 33140 |
| 63 | Goji Group - Research Trials Group | Miami Lakes | Florida | United States | 33016 |
| 64 | Homestead Associates in Research | Miami | Florida | United States | 33032 |
| 65 | Optimus U | Miami | Florida | United States | 33125 |
| 66 | Finlay Medical Research-Miami | Miami | Florida | United States | 33126 |
| 67 | Miami Jewish health | Miami | Florida | United States | 33137 |
| 68 | Elite Clinical Research | Miami | Florida | United States | 33144 |
| 69 | Allied Biomedical Research Institute | Miami | Florida | United States | 33155 |
| 70 | Future Care Solution | Miami | Florida | United States | 33165 |
| 71 | New Horizon Research Center | Miami | Florida | United States | 33165 |
| 72 | Florida International Research Center | Miami | Florida | United States | 33173 |
| 73 | Ezy Medical Research | Miami | Florida | United States | 33175 |
| 74 | Brainstorm Research | Miami | Florida | United States | 33176 |
| 75 | Miami Dade Medical Research Institute, LLC | Miami | Florida | United States | 33176 |
| 76 | Visionary Investigators Network | Miami | Florida | United States | 33176 |
| 77 | Collier Neurologic Specialists | Naples | Florida | United States | 34105 |
| 78 | Suncoast Clinical Research | New Port Richey | Florida | United States | 34652 |
| 79 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
| 80 | Sensible Healthcare, LLC | Ocoee | Florida | United States | 34761 |
| 81 | Medical Research Group of Central Florida | Orange City | Florida | United States | 32763 |
| 82 | Synexus Clinical Research US, Inc - Orlando | Orlando | Florida | United States | 32806 |
| 83 | Headlands Research Orlando | Orlando | Florida | United States | 32819 |
| 84 | IMIC, Inc. | Palmetto Bay | Florida | United States | 33157 |
| 85 | Synergy Clinical Research, LLC | Pensacola | Florida | United States | 32504 |
| 86 | Quantum Laboratories Inc - Pompano Beach | Pompano Beach | Florida | United States | 33064 |
| 87 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 88 | Suncoast Neuroscience Associates | Saint Petersburg | Florida | United States | 33713 |
| 89 | Intercoastal Medical Group | Sarasota | Florida | United States | 34239 |
| 90 | Roskamp Institute Clinical Trials Division | Sarasota | Florida | United States | 34243 |
| 91 | Alzheimer's Research and Treatment Center | Stuart | Florida | United States | 34997 |
| 92 | Brain Matters Research | Stuart | Florida | United States | 34997 |
| 93 | Tallahassee Neurology | Tallahassee | Florida | United States | 32308 |
| 94 | Axiom Clinical Research of Florida | Tampa | Florida | United States | 33609 |
| 95 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
| 96 | USF Health Byrd Alzheimer's Institute | Tampa | Florida | United States | 33613 |
| 97 | Synexus Clinical Research US, Inc. | The Villages | Florida | United States | 32162 |
| 98 | Alzheimer's Research and Treatment Center | Wellington | Florida | United States | 33414 |
| 99 | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | United States | 33407 |
| 100 | Conquest Research | Winter Park | Florida | United States | 32789 |
| 101 | Charter Research | Winter Park | Florida | United States | 32792 |
| 102 | Gwinnett Research Inst | Buford | Georgia | United States | 30519 |
| 103 | Columbus Memory Center, PC | Columbus | Georgia | United States | 31909 |
| 104 | ARS-Neurostudies | Decatur | Georgia | United States | 30030 |
| 105 | Center for Advanced Research and Education | Gainesville | Georgia | United States | 30501 |
| 106 | Northwest Clinical Trials | Boise | Idaho | United States | 83704 |
| 107 | Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | United States | 60640 |
| 108 | AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research | Elk Grove Village | Illinois | United States | 60007 |
| 109 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 110 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 111 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 112 | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | United States | 46256 |
| 113 | McFarland Clinic, PA | Ames | Iowa | United States | 50010 |
| 114 | MercyOne Northeast Iowa Family Medicine & Residency | Waterloo | Iowa | United States | 50702 |
| 115 | University of Kansas Medical Center | Fairway | Kansas | United States | 66205 |
| 116 | College Park Family Care Center/Multi Specialty Clinical Res | Overland Park | Kansas | United States | 66212 |
| 117 | Cotton O'Neil Clinic | Topeka | Kansas | United States | 66606 |
| 118 | Ascension Via Christi Research | Wichita | Kansas | United States | 67214 |
| 119 | Maine Medical Center-Maine Medical Partners Neurology | Scarborough | Maine | United States | 04074 |
| 120 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 121 | Boston Clinical Trials | Boston | Massachusetts | United States | 02131 |
| 122 | NECCR PrimaCare Research | Fall River | Massachusetts | United States | 02721 |
| 123 | BTC Network | New Bedford | Massachusetts | United States | 02740 |
| 124 | Boston Center for Memory | Newton | Massachusetts | United States | 02459 |
| 125 | Donald S. Marks M.D., P.C. | Plymouth | Massachusetts | United States | 02360 |
| 126 | Alzheimers Disease Center | Quincy | Massachusetts | United States | 02169 |
| 127 | MedVadis Research Corporation | Waltham | Massachusetts | United States | 02451 |
| 128 | Adams Clinical | Watertown | Massachusetts | United States | 02472 |
| 129 | QUEST Research Institute | Farmington Hills | Michigan | United States | 48334 |
| 130 | Precise Research Centers | Flowood | Mississippi | United States | 39232 |
| 131 | Olive Branch Family Medical Center | Olive Branch | Mississippi | United States | 38654 |
| 132 | Missouri Memory Center | Bolivar | Missouri | United States | 65613 |
| 133 | Clinical Research Professionals | Chesterfield | Missouri | United States | 63005 |
| 134 | North Kansas City Hospital | North Kansas City | Missouri | United States | 64116 |
| 135 | Sharlin Health Neuroscience Research Center | Ozark | Missouri | United States | 65721 |
| 136 | Arch Clinical Trials, LLC | Saint Louis | Missouri | United States | 63125 |
| 137 | Las Vegas Medical Research | Las Vegas | Nevada | United States | 89113 |
| 138 | The Cognitive and Research Center of New Jersey | Springfield | New Jersey | United States | 07081 |
| 139 | Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | United States | 08755 |
| 140 | Bio Behavioral Health | Toms River | New Jersey | United States | 08755 |
| 141 | University of New Mexico Center for Memory and Aging | Albuquerque | New Mexico | United States | 33014 |
| 142 | Albany Medical College | Albany | New York | United States | 12208 |
| 143 | Neurological Associates Albany | Albany | New York | United States | 12208 |
| 144 | Dent Neurologic Institute | Amherst | New York | United States | 14226 |
| 145 | University of Buffalo | Buffalo | New York | United States | 14203 |
| 146 | Clarity Clinical Research, LLC | East Syracuse | New York | United States | 13057 |
| 147 | New York University Medical Center | New York | New York | United States | 10016 |
| 148 | University of Rochester | Rochester | New York | United States | 14640 |
| 149 | Richmond Behavioral Associates | Staten Island | New York | United States | 10312 |
| 150 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 151 | Carolinas Healthcare System | Charlotte | North Carolina | United States | 28211 |
| 152 | Guilford Neurologic Research, PA | Greensboro | North Carolina | United States | 27405 |
| 153 | Alzheimer's Memory Center | Matthews | North Carolina | United States | 28105 |
| 154 | Carteret Medical Group | Morehead City | North Carolina | United States | 28557 |
| 155 | Acellacare, Us, Inc | Winston-Salem | North Carolina | United States | 27103 3914 |
| 156 | NeuroScience Research Center, LLC | Canton | Ohio | United States | 44718 |
| 157 | Valley Medical Primary Care | Centerville | Ohio | United States | 45459 |
| 158 | Velocity Clinical Research, Cleveland | Cleveland | Ohio | United States | 44122 |
| 159 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 160 | University of Cincinnati Physicians Company, LLC | Dayton | Ohio | United States | 45417 |
| 161 | Neurology Diagnostics, Inc. | Dayton | Ohio | United States | 45459 |
| 162 | IPS Research Company | Oklahoma City | Oklahoma | United States | 73106 |
| 163 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 164 | Central States Research | Tulsa | Oklahoma | United States | 74136 |
| 165 | Summit Research Network Inc | Portland | Oregon | United States | 97210 |
| 166 | Center for Cognitive Health | Portland | Oregon | United States | 97225 |
| 167 | Abington Neurological Associates, Ltd. | Abington | Pennsylvania | United States | 19001 |
| 168 | The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | United States | 19046 |
| 169 | University of Pennsylvania Heath System | Philadelphia | Pennsylvania | United States | 19104 |
| 170 | Keystone Clinical Studies | Plymouth Meeting | Pennsylvania | United States | 19462 |
| 171 | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | United States | 02914 |
| 172 | Prism Health Richland Department of Neurology Research | Columbia | South Carolina | United States | 29203 |
| 173 | Neurology Clinic, P.C. | Cordova | Tennessee | United States | 38018 |
| 174 | Clinical Neuroscience Solutions PA | Memphis | Tennessee | United States | 38119 |
| 175 | Senior Adults Specialty Research | Austin | Texas | United States | 78757 |
| 176 | Gadolin Research, LLC | Beaumont | Texas | United States | 77702 |
| 177 | Kerwin Research Center, LLC | Dallas | Texas | United States | 75231 |
| 178 | Neurology Consultants of Dallas, PA | Dallas | Texas | United States | 75243 |
| 179 | Insite Clinical Research LLC | DeSoto | Texas | United States | 75115 |
| 180 | Houston Methodist Research Ins | Houston | Texas | United States | 77030 |
| 181 | University of Texas Medical School at Houston | Houston | Texas | United States | 77030 |
| 182 | Central Texas Neurology Consultants | Round Rock | Texas | United States | 78681 |
| 183 | Glenn Biggs Institute | San Antonio | Texas | United States | 78229 |
| 184 | The Memory Clinic | Bennington | Vermont | United States | 05201 |
| 185 | Integrated Neurology Services | Falls Church | Virginia | United States | 22043 |
| 186 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23510 |
| 187 | National Clinical Research, Inc | Richmond | Virginia | United States | 23294 |
| 188 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
| 189 | Booth Gardner Parkinson's Care Center | Kirkland | Washington | United States | 98034 |
| 190 | University of Washington - Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 191 | Kingfisher Cooperative, LLC | Spokane | Washington | United States | 99202 |
| 192 | Universal Research Group | Tacoma | Washington | United States | 98405 |
| 193 | Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | United States | 53226 |
| 194 | St. Vincents Hospital Sydney | Darlinghurst | New South Wales | Australia | 2010 |
| 195 | Central Coast Neurosciences Research | Erina | New South Wales | Australia | 2250 |
| 196 | KaRa Institute of Neurological Diseases | Macquarie Park | New South Wales | Australia | 2113 |
| 197 | HammondCare | Sydney | New South Wales | Australia | 2065 |
| 198 | Delmont Private Hospital | Glen Iris | Victoria | Australia | 3146 |
| 199 | HammondCare | Malvern | Victoria | Australia | 3144 |
| 200 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 201 | NeuroCentrix | Noble Park | Victoria | Australia | 3174 |
| 202 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 203 | OCT Research ULC | Kelowna | British Columbia | Canada | V1Y 1Z9 |
| 204 | True North Clinical Research Halifax, LLC | Halifax | Nova Scotia | Canada | B3S 1N2 |
| 205 | True North Clinical Research | New Minas | Nova Scotia | Canada | B4N 3R7 |
| 206 | SKDS Research Inc. | Newmarket | Ontario | Canada | L3Y 5G8 |
| 207 | Elizabeth Bruyere Health Centre | Ottawa | Ontario | Canada | K1R 7A5 |
| 208 | Ottawa Memory Clinic | Ottawa | Ontario | Canada | K1Z 1G3 |
| 209 | Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | Canada | K9H 2P4 |
| 210 | Bluewater Clinical Research Group Inc. | Sarnia | Ontario | Canada | N7T 4X3 |
| 211 | Toronto Memory Program | Toronto | Ontario | Canada | M3B2S7 |
| 212 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 213 | Baycrest Health Sciences | Toronto | Ontario | Canada | M6A 2E1 |
| 214 | Clinique de la Mémoire de l'Outaouais | Gatineau | Quebec | Canada | J8T 8J1 |
| 215 | MoCA Clinic and Institute | Greenfield Park | Quebec | Canada | J4V 2J2 |
| 216 | Alpha Recherche Clinique Lebourgneuf | Quebec City | Quebec | Canada | G2J 0C4 |
| 217 | Q&T Research Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1J 2G2 |
| 218 | Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1L 0H8 |
| 219 | ALPHA Recherche Clinique | Quebec | Canada | G3K 2P8 | |
| 220 | A-Shine | Pilsen | Plzeň-město | Czechia | 312 00 |
| 221 | Clintrial s.r.o. | Praha | Praha 10 | Czechia | 100 00 |
| 222 | Clinline s.r.o. Psychiatricka ambulance Medic | Hostivice | Czechia | 253 01 | |
| 223 | Brain-Soul Therapy | Kladno | Czechia | 272 01 | |
| 224 | Neurologicka ordinace | Praha 6 | Czechia | 160 00 | |
| 225 | Neuropsychiatrie s.r.o | Praha 6 | Czechia | 160 00 | |
| 226 | Nagoya Ekisaikai Hospital | Nagoya-shi | Aichi-Ken | Japan | 454-8502 |
| 227 | Chubu Rosai Hospital | Nagoya | Aichi | Japan | 455-8530 |
| 228 | Kojunkai Daido Clinic | Nagoya | Aichi | Japan | 4570818 |
| 229 | National Center for Geriatrics and Gerontology | Obu City | Aichi | Japan | 4748511 |
| 230 | Inage Neurology and Memory Clinic | Inage | Chiba-Ken | Japan | 263-0043 |
| 231 | Matsui e-clinic | Akashi | Hyogo | Japan | 673-0891 |
| 232 | Himeji Central Hospital Clinic | Himeji | Hyogo | Japan | 672-8043 |
| 233 | Kobe University Hospital | Kobe | Hyogo | Japan | 650-0017 |
| 234 | Kobe City Medical Center General Hospital | Kobe | Hyogo | Japan | 650-0047 |
| 235 | Kakigi Clinic | Kobe | Hyogo | Japan | 657-0825 |
| 236 | Tokyo Medical University Ibaraki Medical Center | Inashiki | Ibaraki | Japan | 300-0332 |
| 237 | Memory Clinic Toride | Toride | Ibaraki | Japan | 302-0004 |
| 238 | Yokohama City Minato Red Cross Hospital | Yokohama-shi | Kanagawa | Japan | 231-8682 |
| 239 | Koseikai Takeda Hospital | Kyoto Shimogyo-Ku | Kyoto | Japan | 600-8558 |
| 240 | Oita University Hospital | Yufu | Oita | Japan | 879-5503 |
| 241 | Katayama Medical Clinic | Kurashiki | Okayama | Japan | 710-0813 |
| 242 | Honmachi Clinic | Ikeda | Osaka | Japan | 563-0058 |
| 243 | Takatsuki General Hospital | Takatsuki | Osaka | Japan | 569-1192 |
| 244 | Medical Corporation Chiseikai Tokyo Center Clinic | Chuo-ku | Tokyo | Japan | 103-0028 |
| 245 | Tokyo aSBo Clinic | Chuo-ku | Tokyo | Japan | 104 0031 |
| 246 | Moriyama Neuro Center Hospital | Edogawa-ku | Tokyo | Japan | 134-0088 |
| 247 | P-One Clinic | Hachioji | Tokyo | Japan | 192-0071 |
| 248 | Makita General Hospital | Ota-ku | Tokyo | Japan | 144-0051 |
| 249 | Clinical Research Hospital Tokyo | Shinjuku-ku | Tokyo | Japan | 162-0053 |
| 250 | Tokyo Metro Bokutoh Hospital | Sumida-ku | Tokyo | Japan | 130-0022 |
| 251 | Hiroshima Neurology Clinic | Hiroshima | Japan | 732-0822 | |
| 252 | Ishikawa Clinic | Kyoto | Japan | 606-0851 | |
| 253 | National hospital Organization Utano National Hospital | Kyoto | Japan | 616-8255 | |
| 254 | Oita Prefectural Hospital | Oita | Japan | 870-8511 | |
| 255 | Itsuki Hospital | Tokushima | Japan | 770-0852 | |
| 256 | Nippon Medical School Hospital | Tokyo | Japan | 113-8603 | |
| 257 | QPS Netherlands B.V | Leeuwarden | Fryslân | Netherlands | 8934 AD |
| 258 | Brain Research Center | Amsterdam | Noord-Holland | Netherlands | 1081 GN |
| 259 | Brain Research Center Zwolle | Zwolle | Overijssel | Netherlands | 8025 AZ |
| 260 | Brain Research Center | Noord-Brabant | Netherlands | 5223 LA | |
| 261 | Wroclawskie Centrum Alzheimerowskie | Wroclaw | Dolnośląskie | Poland | 53-659 |
| 262 | Centrum Medyczne NEUROMED | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-163 |
| 263 | Osrodek Badawczo-Naukowo Dydaktyczny Chorob Otepiennych | Scinawa | Lower Silesian | Poland | 59 330 |
| 264 | Centrum Medyczne AMED | Warsaw | Mazowieckie | Poland | 01-518 |
| 265 | Podlaskie Centrum Psychogeriatrii | Białystok | Podlaskie | Poland | 15-756 |
| 266 | Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomorskie | Poland | 80-546 |
| 267 | Centrum Medyczne Euromedis | Szczecin | Zachodniopomorskie | Poland | 70-111 |
| 268 | KLIMED | Bialystok | Poland | 15704 | |
| 269 | Diamond Clinic | Krakow | Poland | 31-559 | |
| 270 | Prywatny Gabinet Lekarski U.Chyrchel | Lublin | Poland | 20-093 | |
| 271 | Nzoz Neuro - Kard | Poznan | Poland | 61-853 | |
| 272 | Centrum Medyczne SENIOR | Sopot | Poland | 81-855 | |
| 273 | Centrum Medyczne NeuroProtect | Warszawa | Poland | 01-684 | |
| 274 | Klinika Neuro-Care | Siemianowice Slaskie | Śląskie | Poland | 41-100 |
| 275 | SCB Research Center | Bayamon | Puerto Rico | 00961 | |
| 276 | INSPIRA Clinical Research | San Juan | Puerto Rico | 00918 | |
| 277 | Instituto De Neurologia Dra. Ivonne Fraga | San Juan | Puerto Rico | 00918 | |
| 278 | Barbara Diaz-Hernandez MD Research, Inc | San Juan | Puerto Rico | 00926 | |
| 279 | Glasgow Memory Clinic | Motherwell | Great Britain | United Kingdom | ML1 4UF |
| 280 | Re:Cognition Health - London | London | London, City Of | United Kingdom | W1G 9JF |
| 281 | Re:Cognition Health | Guildford | Surrey | United Kingdom | GU2 7YD |
| 282 | Re:Cognition Health - Birmingham | Birmingham | United Kingdom | B16 8LT |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04437511
Other Study ID Numbers:
- 17737
- I5T-MC-AACI
- 2020-000077-25
First Posted:
Jun 18, 2020
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms: