Early Symptomatic Alzheimer's Disease Alzheimer senile psychosis
Conditions
Interventions
Patients will be randomized in a 1:1 ratio to receive respectively:
- Donanemab: 700 mg IV Q4W for first 3 doses and then 1400 mg IV Q4W
- Placebo
Treatment will occur every four weeks, where patien
Sponsors
Eli Lilly
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 60 to 85 years of age inclusive, at the time of signing the informed consent. 2. Gradual and progressive change in memory function reported by the participant or informant for >=6 months. 3. An MMSE score of 20 to 28 (inclusive) at LEAD-IN SCREENING or COMPLETE SCREENING, 4. Meet flortaucipir F18 scan (central read) criteria 5. Meet florbetapir F18 scan (central read) criteria 6. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times. 7. Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening. 8. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. 9. Males and females will be eligible for this study. 10.Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Exclusion criteria: 12. Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson*s disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures). 13. Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator*s opinion, could interfere with the analyses in this study; or has a life expectancy of 4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening. 23. Sensitivity to florbetapir F18 or flortaucipir F18. 24. Poor venous access. 25. Contraindication to PET. 26. Present or planned exposure to ionizing radiation that, in combination with the planned administration of study PET ligands, would result in a cumulative exposure that exceeds local recommended exposure limits. 27. A corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec (women) at screening (as determined at the investigational site). The site may request a central read prior to making determination of thi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iADRS change from baseline through Week 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline through Week 76 as measured by: • iADRS • CDR-SB • ADAS-Cog13 score • ADCS-iADL score • MMSE score Change in brain amyloid plaque deposition from baseline through Week 76 as measured by florbetapir F18 PET scan Change in brain tau deposition from baseline through Week 76 as measured by flortaucipir F18 PET scan Change in volumetric MRI measures from baseline through Week 76 Standard safety assessments: Spontaneously reported AEs, Clinical laboratory tests, Vital sign and body weight measurements, 12-lead ECGs, Physical and neurological examinations - MRI (ARIA and emergent radiological findings) - Infusion related reactions - C-SSRS Plasma PK of donanemab ADAs against donanemab including • treatment emergent ADAs • neutralizing antibodies | — |
Countries
Netherlands
Outcome results
None listed