A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) | NCT05026866 | Trialant

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) | NCT05026866 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.

Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.

Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

Have adequate literacy, vision, and hearing for neuropsychological testing at screening.

Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Treatment Extension: (Study Period II Placebo Group Only)

Are actively participating in Study AACM at the conclusion of Study Period III.

Exclusion Criteria:

Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.

Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.

History of cancer with high risk of recurrence and preventing completion of the trial.

History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).

Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.

Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.

Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.

Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.

Have received active immunization against amyloid beta (Aβ) in any other study.

Have received active immunization against Aβ in any other study.

Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Addendum 7 Exclusion Criteria:

Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

Parkway Medical Center

Birmingham, Alabama 35215, United States

Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive

Homewood, Alabama 35209, United States

Rehabilitation & Neurological Services

Huntsville, Alabama 35805, United States

Care Access - 801 South Power Road, Mesa

Mesa, Arizona 85206, United States

Banner Alzheimer's Institute

Phoenix, Arizona 85006, United States

Banner Alzheimer's Institute Tucson

Tucson, Arizona 85718, United States

Center for Neurosciences

Tucson, Arizona 85718, United States

Care Access - Berkeley

Berkeley, California 94705, United States

Care Access - Beverly Hills

Beverly Hills, California 90212, United States

Velocity Clinical Research, Chula Vista

Chula Vista, California 91911, United States

Valley Clinical Trials, Inc.

Covina, California 91723, United States

Neurology Center of North Orange County

Fullerton, California 92835, United States

Care Access - Gilroy

Gilroy, California 95020, United States

Marvel Clinical Research

Huntington Beach, California 92647, United States

Care Access Research - Huntington Beach

Huntington Beach, California 92648, United States

Irvine Clinical Research

Irvine, California 92614, United States

Option Care - Irvine

Irvine, California 92618, United States

Kaizen Brain Center

La Jolla, California 92037, United States

Velocity Clinical Research, San Diego

La Mesa, California 91942, United States

Pacific Research Network

Lemon Grove, California 91945, United States

Healthy Brain Clinic

Long Beach, California 90804, United States

Neurovations

Napa, California 94558, United States

Care Access - Newport Beach

Newport Beach, California 92660, United States

Valley Clinical Trials, Inc.

Northridge, California 91325, United States

Inland Psychiatric Medical Group

Redlands, California 92373, United States

Anderson Clinical Research

Redlands, California 92374, United States

Artemis Institute for Clinical Research

Riverside, California 92503, United States

Option Care - Riverside

Riverside, California 92507, United States

Clinical Trials Research

Sacramento, California 95821, United States

Artemis Institute for Clinical Research

San Diego, California 92123, United States

Ray Dolby Brain Health Center

San Francisco, California 94114, United States

Care Access - Los Gatos

San Jose, California 95124, United States

Syrentis Clinical Research

Santa Ana, California 92705, United States

Care Access - Santa Clarita

Santa Clarita, California 91321, United States

Option Care - Los Angeles South

Santa Fe Springs, California 90670, United States

Providence Medical Foundation

Santa Rosa, California 95403, United States

Mazur, Statner, Dutta, Nathan, PC

Thousand Oaks, California 91360, United States

Tilda Research

Tustin, California 92780, United States

Velocity Clinical Research, Panorama City

Van Nuys, California 91405, United States

Infectious Disease Doctors Medical Group, APC

Walnut Creek, California 94598, United States

Care Access - Aurora

Aurora, Colorado 80012, United States

Mountain Neurological Research Center

Basalt, Colorado 81621, United States

Denver Neurological Research

Denver, Colorado 80210, United States

Invicro

New Haven, Connecticut 06510, United States

JEM Research Institute

Atlantis, Florida 33462, United States

VIN-Julie Schwartzbard

Aventura, Florida 33180, United States

Neurology Offices of South Florida

Boca Raton, Florida 33428, United States

Excel Medical Clinical Trials

Boca Raton, Florida 33434, United States

SFM Clinical Research

Boca Raton, Florida 33487, United States

Bradenton Research Center, Inc.

Bradenton, Florida 34205, United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida 33765, United States

Care Access - Daytona Beach

Daytona Beach, Florida 32114, United States

Care Access - Delray Beach

Delray Beach, Florida 33484, United States

Finlay Medical Research

Greenacres City, Florida 33467, United States

Indago Research & Health Center, Inc

Hialeah, Florida 33012, United States

Infinity Clinical Research, LLC

Hollywood, Florida 33024, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216, United States

Care Access - Guava Street

Lady Lake, Florida 32159, United States

Accel Research Sites - St. Pete-Largo Clinical Research Unit

Largo, Florida 33777, United States

ClinCloud - Maitland

Maitland, Florida 32751, United States

K2 Medical Research

Maitland, Florida 32751, United States

ClinCloud - Viera

Melbourne, Florida 32940, United States

Merritt Island Medical Research, LLC

Merritt Island, Florida 32952, United States

Optimus U Corporation

Miami, Florida 33125, United States

Finlay Medical Research

Miami, Florida 33126, United States

VIN-Andrew Lerman

Miami, Florida 33133, United States

South Florida Research Phase I-IV

Miami, Florida 33166, United States

Brainstorm Research Group

Miami, Florida 33176, United States

IMIC, Inc.

Miami, Florida 33176, United States

VIN-Victor Faradji

Miami, Florida 33176, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida 33014, United States

Adult Medicine of Lake County

Mt. Dora, Florida 32757, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida 34652, United States

Renstar Medical Research

Ocala, Florida 34470, United States

Charter Research - Winter Park

Orlando, Florida 32803, United States

Headlands Research Orlando

Orlando, Florida 32806, United States

Pines Care Research Center, LLC

Pembroke Pines, Florida 33024, United States

VIN- Margarita Almeida El-Ramey

Pembroke Pines, Florida 33026, United States

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida 32504, United States

Progressive Medical Research

Port Orange, Florida 32127, United States

Care Access - Tamarac

Tamarac, Florida 33321, United States

Clinical Research of West Florida

Tampa, Florida 33606, United States

Stedman Clinical Trials

Tampa, Florida 33613, United States

Vicis Clinical Research

Tampa, Florida 33615, United States

Care Access - Tampa

Tampa, Florida 33625, United States

Coram CVS/Specialty Infusion Services - Tampa

Tampa, Florida 33634, United States

K2 Medical Research - Tampa

Tampa, Florida 33634, United States

Charter Research - Lady Lake

The Villages, Florida 32162, United States

Palm Beach Research Center

West Palm Beach, Florida 33409, United States

Conquest Research

Winter Park, Florida 32789, United States

Masters of Clinical Research

Augusta, Georgia 30909, United States

iResearch Atlanta

Decatur, Georgia 30030, United States

Center for Advanced Research & Education

Gainesville, Georgia 30501, United States

Meridian Clinical Research, LLC

Savannah, Georgia 31406, United States

SKY Clinical Research Network Group-Blake

Union City, Georgia 30291, United States

North Georgia Clinical Research

Woodstock, Georgia 30189, United States

Northwest Clinical Trials

Boise, Idaho 83704, United States

IMA Clinical Research Chicago

Chicago, Illinois 60602, United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois 60640, United States

Uptown Research Institute

Chicago, Illinois 60640, United States

AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois 60007, United States

Care Access - Fairview Heights

Fairview Heights, Illinois 62208, United States

Great Lakes Clinical Trials - Gurnee

Gurnee, Illinois 60031, United States

Accellacare - DuPage

Lombard, Illinois 60148, United States

Coram CVS/Specialty Infusion Services - Fort Wayne

Fort Wayne, Indiana 46805, United States

Care Access - South Indianapolis

Indianapolis, Indiana 46227, United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana 46256, United States

Covenant Medical Center

Waterloo, Iowa 50702, United States

College Park Specialty Center

Overland Park, Kansas 66212, United States

Norton Brownsboro Hospital

Louisville, Kentucky 40241, United States

Optum Infusion - Baton Rouge

Baton Rouge, Louisiana 70809, United States

Care Access - Lake Charles

Lake Charles, Louisiana 70601, United States

MD Medical Research

Oxon Hill, Maryland 20745, United States

ActivMed Practices and Research

Methuen, Massachusetts 01844, United States

Boston Center for Memory

Newton, Massachusetts 02459, United States

Care Access - Quincy

Quincy, Massachusetts 02169, United States

MedVadis Research Corporation

Waltham, Massachusetts 02451, United States

Revival Research Institute

Southfield, Michigan 48075, United States

Minneapolis Clinic of Neurology - Burnsville Office

Burnsville, Minnesota 55337, United States

Coram CVS/Specialty Infusion Services - Mendota Heights

Mendota Heights, Minnesota 55120, United States

SKY Clinical Research Network Group - Hall

Fayette, Mississippi 39069, United States

SKY Clinical Research Network Group-Quinn

Ridgeland, Mississippi 39157, United States

Citizens Memorial Hospital District

Bolivar, Missouri 65613, United States

Clinical Research Professionals

Chesterfield, Missouri 63005, United States

IMA Clinical Research - St. Louis

St Louis, Missouri 63117, United States

Coram CVS/Specialty Infusion Services - Henderson

Henderson, Nevada 89014, United States

Option Care - Las Vegas

Las Vegas, Nevada 89102, United States

Las Vegas Medical Research

Las Vegas, Nevada 89128, United States

IMA Clinical Research Hoboken

Hoboken, New Jersey 07030, United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey 07081, United States

IMA Clinical Research Warren

Warren Township, New Jersey 07059, United States

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico 87109, United States

IMA Clinical Research Albany

Albany, New York 12205, United States

Neurological Associates Albany

Albany, New York 12208, United States

Velocity Clinical Research, Syracuse

East Syracuse, New York 13057, United States

IMA Clinical Research Westchester

Hartsdale, New York 10530, United States

IMA Clinical Research

New York, New York 10036, United States

South Shore Neurologic Associates

Patchogue, New York 11772, United States

Richmond Behavioral Associates

Staten Island, New York 10314, United States

Prime Global Research

The Bronx, New York 10456, United States

Asheville Neurology Specialists

Asheville, North Carolina 28806, United States

Care Access - Charlotte

Charlotte, North Carolina 28210, United States

Care Access - Fayetteville

Fayetteville, North Carolina 28314, United States

Care Access - Greensboro

Greensboro, North Carolina 27401, United States

Medication Management

Greensboro, North Carolina 27405, United States

Care Access - Kinston

Kinston, North Carolina 28501, United States

Monroe Biomedical Research

Monroe, North Carolina 28112, United States

Carteret Medical Group

Morehead City, North Carolina 28557, United States

Care Access - Raleigh

Raleigh, North Carolina 27607, United States

Accellacare - Winston-Salem

Winston-Salem, North Carolina 27103, United States

NeuroScience Research Center

Canton, Ohio 44718, United States

Hometown Urgent Care and Research - Cincinnati

Dayton, Ohio 45424, United States

Neurology Diagnostics, Inc.

Dayton, Ohio 45459, United States

Care Access - Lima

Lima, Ohio 45805, United States

North Star Medical Research

Middleburg Heights, Ohio 44130, United States

Care Access - Youngstown

Poland, Ohio 44514, United States

Central States Research

Tulsa, Oklahoma 74136, United States

Optum Infusion - Bend

Bend, Oregon 97701, United States

Velocity Clinical Research, Medford

Medford, Oregon 97504, United States

Center for Cognitive Health

Portland, Oregon 97225, United States

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania 19046, United States

Care Access - Pottsville

Pottsville, Pennsylvania 17901, United States

Care Access Research - Warwick

Warwick, Rhode Island 02886, United States

Care Access - Anderson

Anderson, South Carolina 29621, United States

Velocity Clinical Research, Anderson

Anderson, South Carolina 29621, United States

VitaLink Research - Columbia

Columbia, South Carolina 29204, United States

Velocity Clinical Research, Gaffney

Gaffney, South Carolina 29340, United States

VitaLink Research - Greenville

Greenville, South Carolina 29615, United States

Care Access - Mauldin

Mauldin, South Carolina 29662, United States

VitaLink Research - Spartanburg

Spartanburg, South Carolina 29303, United States

VitaLink Research - Union

Union, South Carolina 29379, United States

Health Concepts

Rapid City, South Dakota 57702, United States

Neurology Clinic

Cordova, Tennessee 38018, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee 38119, United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas 78749, United States

Senior Adults Specialty Research

Austin, Texas 78757, United States

Gadolin Research

Beaumont, Texas 77702, United States

Headlands Research - Brownsville

Brownsville, Texas 78526, United States

Conroe Willis Medical Research

Conroe, Texas 77304, United States

Advanced Neuro Research Center - ANRC

El Paso, Texas 79912, United States

Care Access - Georgetown

Georgetown, Texas 78633, United States

Optum Infusion - Houston

Houston, Texas 77054, United States

The University of Texas Health Science Center at Houston

Houston, Texas 77054, United States

Next Level Urgent Care

Houston, Texas 77057, United States

Family Practice Center

McAllen, Texas 78501, United States

El Faro Health and Therapeutics

Rio Grande City, Texas 78582, United States

Benchmark Research - Knickerbocker

San Angelo, Texas 76904, United States

Diagnostics Research Group

San Antonio, Texas 78229, United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231, United States

Texas Valley Clinical Research

Weslaco, Texas 78596, United States

The Memory Clinic

Bennington, Vermont 05201-9810, United States

Care Access - Arlington

Arlington, Virginia 22206, United States

Option Care - Chantilly

Chantilly, Virginia 20151, United States

Dominion Medical Associates, Inc.

Richmond, Virginia 23219, United States

Northwest Clinical Research Center

Bellevue, Washington 98007, United States

Universal Research Group

Tacoma, Washington 98405, United States

Optum Infusion - Woodinville

Woodinville, Washington 98072, United States

Exemplar Research

Morgantown, West Virginia 26505, United States

The University of Tokyo Hospital

Bunkyō City, 113-8654, Japan

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027, Japan

Fukuwa Clinic

Chūōku, 104-0031, Japan

Tokyo Asbo Clinic

Chūōku, 104-0031, Japan

P-One Clinic

Hachiōji, 192-0071, Japan

AMC Nishiumeda Clinic

Osaka, 530-0001, Japan

National Center for Geriatrics and Gerontology

Ōbu, 474-8511, Japan

Samoncho Clinic

Shinjuku, 160-0017, Japan

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, 160-0008, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, 565-0853, Japan

Tokyo Metropolitan Geriatric Hospital

tabashi City, 173-0015, Japan

Oita University Hospital

Yufu, 879-5593, Japan

SCB Research Center

Bayamón, 00961, Puerto Rico

Dr. Samuel Sanchez PSC

Caguas, 00727, Puerto Rico

INSPIRA Clinical Research

San Juan, 00918, Puerto Rico

Instituto De Neurologia Dra. Ivonne Fraga

San Juan, 00918, Puerto Rico

Mindful Medical Research

San Juan, 00918, Puerto Rico

University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility

San Juan, 00935, Puerto Rico