The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.
Eligibility
Sex
ALL
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Time to Clinical Progression of Composite Endpoint as Measured by Clinical Dementia Rating (CDR) in the Primary Study Population (Baseline CDR-Global Score [GS 0]) — Estimated up to Week 332 Time to clinical progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of Alzheimer's Disease (AD) dementia
Trial sites (216)
Facility
City
Region
Status
Parkway Medical Center
Birmingham
Alabama
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive
Homewood
Alabama
Rehabilitation & Neurological Services
Huntsville
Alabama
Care Access - 801 South Power Road, Mesa
Mesa
Arizona
Banner Alzheimer's Institute
Phoenix
Arizona
Banner Alzheimer's Institute Tucson
Tucson
Arizona
Center for Neurosciences
Tucson
Arizona
Care Access - Berkeley
Berkeley
California
Care Access - Beverly Hills
Beverly Hills
California
Velocity Clinical Research, Chula Vista
Chula Vista
California
Valley Clinical Trials, Inc.
Covina
California
Neurology Center of North Orange County
Fullerton
California
Care Access - Gilroy
Gilroy
California
Marvel Clinical Research
Huntington Beach
California
Care Access Research - Huntington Beach
Huntington Beach
California
Irvine Clinical Research
Irvine
California
Option Care - Irvine
Irvine
California
Kaizen Brain Center
La Jolla
California
Velocity Clinical Research, San Diego
La Mesa
California
Pacific Research Network
Lemon Grove
California
Healthy Brain Clinic
Long Beach
California
Neurovations
Napa
California
Care Access - Newport Beach
Newport Beach
California
Valley Clinical Trials, Inc.
Northridge
California
Inland Psychiatric Medical Group
Redlands
California
Anderson Clinical Research
Redlands
California
Artemis Institute for Clinical Research
Riverside
California
Option Care - Riverside
Riverside
California
Clinical Trials Research
Sacramento
California
Artemis Institute for Clinical Research
San Diego
California
Ray Dolby Brain Health Center
San Francisco
California
Care Access - Los Gatos
San Jose
California
Syrentis Clinical Research
Santa Ana
California
Care Access - Santa Clarita
Santa Clarita
California
Option Care - Los Angeles South
Santa Fe Springs
California
Providence Medical Foundation
Santa Rosa
California
Mazur, Statner, Dutta, Nathan, PC
Thousand Oaks
California
Tilda Research
Tustin
California
Velocity Clinical Research, Panorama City
Van Nuys
California
Infectious Disease Doctors Medical Group, APC
Walnut Creek
California
+ 176 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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