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Also known as A Beta Antibody, Solanezumab
LY2062430 · 8 trials · 5 indications
PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-91 \[best performance\]) and Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Multivariate Disease Progression Model adjusted for Estimated Years to Onset (EYO)and includes all timepoints up to treatment discontinuation. The treatment effect is reported relative to the mutation positive placebo arm. Multivariate Cognitive Endpoint comprising: (i) Wechsler Memory Scale-Revised Logical Memory Delayed Recall Test (MEMUNITS), (ii) Wechsler Adult Intelligence Scale Digit Symbol Substitution Test (WAIS), (iii) Mini-Mental State Examination (MMSE), and (iv) International Shopping List Task (ISLT). Measurements for each test were normalized using the mean (SD) at DIAN-TU-001 baseline for mutation negative subjects. Higher scores indicate more favourable cognitive performance.
The DIAN-Multivariate Cognitive Endpoint (DIAN-MCE) consists of 4 cognitive measures: Wechsler Memory Scale-Revised Logical Memory Delayed Recall Test, Wechsler Adult Intelligence Sale Digit Symbol Substitution Test (WAIS), International Shopping List Task (ISLT), Mini-Mental State Examination (MMSE)
| Arm | Type | Description |
|---|---|---|
| Solanezumab/Solanezumab | EXPERIMENTAL | Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind placebo-controlled period. Participants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444). |
| Placebo/Solanezumab | PLACEBO_COMPARATOR | Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind period. Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444). |
| LY2062430 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Gantenerumab | EXPERIMENTAL | - |
| Solanezumab | EXPERIMENTAL | - |
| Matching placebo (Gantenerumab) | PLACEBO_COMPARATOR | - |
| Matching Placebo (Solanezumab) | PLACEBO_COMPARATOR | - |
| Cognitive Run-in | NO_INTERVENTION | This arm is completed and closed. |
| Gantenerumab Open Label Extension | ACTIVE_COMPARATOR | Subcutaneously every 4 weeks at escalating doses. This arm is completed and closed. |
| E2814 plus lecanemab | EXPERIMENTAL | Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 will receive intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 will receive intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period. |
| Matching placebo (E2814) plus lecanemab | EXPERIMENTAL | Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period. |
| Group 1 | EXPERIMENTAL | Older adults with mild Dementia Alzheimer's Type (DAT) |
| Group 2 | EXPERIMENTAL | Older adult controls with possible Alzheimer's Disease Pathology |
| Group 3 | EXPERIMENTAL | Older adult controls with no evidence of Alzheimer's Disease |
| Group 4 | EXPERIMENTAL | Younger subjects who are assumed to have no cognitive impairment |
| QW | EXPERIMENTAL | IV infusion of 400mg once each week for 2 months |
| Q4W | EXPERIMENTAL | IV infusion of 400mg once every four weeks for 2 months |
| Q8W | EXPERIMENTAL | IV infusion of 400mg once every eight weeks for 2 months |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered IV |
| Solanezumab | DRUG | Administered IV |
| LY2062430 | DRUG | 400 mg intravenously (IV) every 4 weeks for 80 weeks |
| Gantenerumab | DRUG | Subcutaneously every 4 weeks at escalating doses |
| Matching Placebo (Gantenerumab) | DRUG | Subcutaneous injection of placebo every 4 weeks |
| Matching Placebo (Solanezumab) | DRUG | Intravenous infusion of placebo every 4 weeks |
| E2814 | DRUG | Administered intravenously in a blinded fashion |
| Lecanemab | DRUG | Administered intravenously |
| Matching Placebo (E2814) | DRUG | Placebo administered intravenously in a blinded fashion. |
Inclusion Criteria: * Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30 * Has a global Clinical Dementia Rating (CDR) scale score at screening of 0 * Has a Logical Memory II score at screening of 6 to 18 * Has a florbetapir positron emission tomography (PET) scan that shows ...
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LY2062430 is an investigational monoclonal antibody developed by Eli Lilly and Company for Alzheimer's disease. It has been studied in Phase 3 clinical trials in patients with Alzheimer's disease. It is not described as approved and remains an investigational therapy that has completed clinical testing.
LY2062430 was studied for the treatment of Alzheimer's disease, with trials enrolling patients aged 55 years and older with the condition. Its Phase 3 program evaluated whether the antibody could affect progression of Alzheimer's disease. The trials are completed and the drug is investigational.
LY2062430 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the clinical trial program for the antibody in Alzheimer's disease, including the Phase 3 studies and an earlier Phase 2 study.
LY2062430 reached Phase 3 clinical development for Alzheimer's disease. Three trials are recorded: two Phase 3 studies and one Phase 2 study, all completed. No trials are currently active, and the drug is investigational rather than approved.
LY2062430 was evaluated in three completed trials. NCT00905372 and NCT00904683 were Phase 3 studies of the effect of LY2062430 on progression of Alzheimer's disease, enrolling 1,000 and 1,040 participants. NCT00329082 was a Phase 2 study in mild-to-moderate Alzheimer's disease and healthy volunteers.
The LY2062430 clinical program enrolled 2,065 participants across three completed trials. The two Phase 3 studies accounted for 1,000 and 1,040 participants, and the Phase 2 study enrolled 25 participants. All trials were randomized, double-blind, and placebo-controlled.