A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

JRCT ID: jRCT2031220335

Registered date:13/09/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer Disease
• Date of first enrollment: 13/09/2022
• Target sample size: 3300
• Countries of recruitment: Puerto Rico,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Donanemab
Administered intravenously
Other Name: LY3002813
-Drug: Placebo
Administered intravenously

Study Arms
-Experimental: Donanemab
Donanemab administered intravenously (IV)
Intervention: Drug: Donanemab
-Placebo Comparator: Placebo
Placebo is administered intravenously
Intervention: Drug: Placebo

Outcome(s)

Primary Outcome

Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS) [ Time Frame: Estimated Up to Week 182 ]
Time to clinical progression as measured by CDR-GS. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of AD dementia.

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: <= 80age old
• Gender: Both

Include 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 and early-tau 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.

Exclude 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 in any other study.
-Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05026866