Recruiting NCT07602582
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Donanemab, Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia, Plaque, Amyloid. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM
Overview
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
- Drug Donanemab
Administered IV - Drug Placebo
Administered IV
Primary outcome measures
- Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) [Time frame: Baseline through Week 130]
Secondary outcome measures (4)
- Change from Baseline as Measured by Cognitive Function Index (CFI) [Time frame: Baseline through Week 130]
- Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan. [Time frame: Baseline through Week 130]
- Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217) [Time frame: Baseline through Week 130]
- Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab [Time frame: Baseline, Week 52, Week 104]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 52 centers
- Banner Alzheimer's Institute — Phoenix
- Care Access - Huntington Beach — Huntington Beach
- Irvine Clinical Research — Irvine
- Healthy Brain Clinic — Long Beach
- Artemis Institute for Clinical Research — Riverside
- Clinical Trials Research — Sacramento
- Artemis Institute for Clinical Research — San Diego
- Syrentis Clinical Research — Santa Ana
- … and 44 more centers
Japan · 6 centers
- Tokyo-Eki Center-building Clinic — Chūōku
- P-One Clinic — Hachiōji
- National Center for Geriatrics and Gerontology — Ōbu
- Samoncho Clinic — Shinjuku
- Yotsuya Internal Medicine Clinic — Shinjyuku
- Tokyo Metropolitan Institute for Geriatrics and Gerontology — tabashi City
Puerto Rico · 1 center
- SCB Research Center — Bayamón
Identifiers
NCT: NCT07602582 · 27890 · I5T-MC-AACY