A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-A… (NCT05026866) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
United States2,996 participantsStarted 2021-08-27
Plain-language summary
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.
Who can participate
Age range55 Years – 80 Years
SexALL
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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 c…
What they're measuring
1
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])