A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Summary

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Interventions

• Donanemab · DRUG

  Administered IV

• Placebo · DRUG

  Administered IV

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Have completed study AACM Addendum 7.
* Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
* Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
* Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.
* Contraindication to florbetapir F 18 PET.
* Have had history of amyloid-targeting therapy treatment outside donanemab trials.
* Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

Sites (59)

• Banner Alzheimer's Institute, Phoenix, Arizona · NOT_YET_RECRUITING
• Care Access - Huntington Beach, Huntington Beach, California · RECRUITING
• Irvine Clinical Research, Irvine, California · RECRUITING
• Healthy Brain Clinic, Long Beach, California · RECRUITING
• Artemis Institute for Clinical Research, Riverside, California · RECRUITING
• Clinical Trials Research, Sacramento, California · RECRUITING
• Artemis Institute for Clinical Research, San Diego, California · NOT_YET_RECRUITING
• Syrentis Clinical Research, Santa Ana, California · RECRUITING
• Providence Medical Foundation, Santa Rosa, California · RECRUITING
• Infectious Disease Doctors Medical Group, APC, Walnut Creek, California · RECRUITING
• VIN - Aventura, Aventura, Florida · RECRUITING
• Bradenton Research Center, Inc., Bradenton, Florida · RECRUITING
• Finlay Medical Research, Greenacres City, Florida · RECRUITING
• Jacksonville Center for Clinical Research, Jacksonville, Florida · RECRUITING
• K2 Medical Research ORLANDO, Maitland, Florida · RECRUITING
• Merritt Island Medical Research, LLC, Merritt Island, Florida · RECRUITING
• Finlay Medical Research, Miami, Florida · RECRUITING
• VIN-Andrew Lerman, Miami, Florida · RECRUITING
• Indago Research & Health Center, Inc, Miami Lakes, Florida · RECRUITING
• Adult Medicine of Lake County, Inc., Mt. Dora, Florida · RECRUITING
• Suncoast Clinical Research, Inc., New Port Richey, Florida · RECRUITING
• Charter Research - Orlando, Orlando, Florida · RECRUITING
• Headlands Research Orlando, Orlando, Florida · RECRUITING
• Emerald Coast Neurology - Airport Boulevard, Pensacola, Florida · RECRUITING
• Progressive Medical Research, Port Orange, Florida · RECRUITING
• Care Access - Tampa, Tampa, Florida · RECRUITING
• K2 Medical Research - Tampa, Tampa, Florida · NOT_YET_RECRUITING
• Charter Research - The Villages, The Villages, Florida · RECRUITING
• Conquest Research, Winter Park, Florida · RECRUITING
• Center for Advanced Research & Education, Gainesville, Georgia · RECRUITING
• North Georgia Clinical Research, Woodstock, Georgia · RECRUITING
• Northwest Clinical Trials, Boise, Idaho · RECRUITING
• Great Lakes Clinical Trials - Andersonville, Chicago, Illinois · RECRUITING
• Care Access - South Indianapolis, Indianapolis, Indiana · RECRUITING
• Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana · RECRUITING
• Covenant Medical Center, Waterloo, Iowa · NOT_YET_RECRUITING
• Care Access - Lake Charles (Bayou Pines), Lake Charles, Louisiana · RECRUITING
• Boston Center for Memory, Newton, Massachusetts · RECRUITING
• MedVadis Research Corporation, Waltham, Massachusetts · NOT_YET_RECRUITING
• Revival Research Institute, LLC, Southfield, Michigan · NOT_YET_RECRUITING
• Citizens Memorial Hospital District, Bolivar, Missouri · RECRUITING
• Vector Clinical Trials, Las Vegas, Nevada · RECRUITING
• The Cognitive and Research Center of New Jersey, Springfield, New Jersey · RECRUITING
• Monroe Biomedical Research, Monroe, North Carolina · NOT_YET_RECRUITING
• NDx Clinical Research, Inc., Dayton, Ohio · NOT_YET_RECRUITING
• Care Access - Lima, Lima, Ohio · RECRUITING
• Senior Adults Specialty Research, Austin, Texas · NOT_YET_RECRUITING
• Gadolin Research, Beaumont, Texas · RECRUITING
• The University of Texas Health Science Center at Houston, Houston, Texas · RECRUITING
• Consano Clinical Research, LLC, Shavano Park, Texas · NOT_YET_RECRUITING
• Northwest Clinical Research Center, Bellevue, Washington · RECRUITING
• Universal Research Group, Tacoma, Washington · RECRUITING
• Tokyo-Eki Center-building Clinic, Chūōku, Japan · NOT_YET_RECRUITING
• P-One Clinic, Hachiōji, Japan · NOT_YET_RECRUITING
• National Center for Geriatrics and Gerontology, Ōbu, Japan · NOT_YET_RECRUITING
• Samoncho Clinic, Shinjuku, Japan · NOT_YET_RECRUITING
• Yotsuya Internal Medicine Clinic, Shinjyuku, Japan · NOT_YET_RECRUITING
• Tokyo Metropolitan Institute for Geriatrics and Gerontology, tabashi City, Japan · NOT_YET_RECRUITING
• SCB Research Center, Bayamón, Puerto Rico · NOT_YET_RECRUITING