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Also known as LY2062430, A Beta Antibody
Solanezumab · 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 ...
Solanezumab is an investigational monoclonal antibody being studied for Alzheimer's disease and cognition disorders. It has been tested in patients with Alzheimer's disease, including dominantly inherited early onset forms caused by genetic mutations, as well as in older individuals at risk for memory loss. It is not an approved treatment.
Solanezumab targets amyloid precursor protein, or APP. It is a monoclonal antibody designed to bind this target, which is central to the amyloid pathway implicated in Alzheimer's disease. This binding agent mechanism underlies its investigation as a potential disease modifying treatment for Alzheimer's disease.
Solanezumab is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly has sponsored the clinical trial program evaluating the antibody across Alzheimer's disease and cognition disorder populations.
Solanezumab is in Phase 2 development. It is an investigational monoclonal antibody and is not FDA approved. Its clinical program includes Phase 2 and Phase 3 studies, with the most recent Phase 2 trial in dominantly inherited Alzheimer's disease completed.
Solanezumab has been evaluated in trials including NCT04623242 and NCT01760005, both Phase 2 studies in dominantly inherited Alzheimer's disease, NCT02008357, a Phase 3 trial in older individuals at risk for memory loss, and NCT01148498, a Phase 2 biomarker study in patients with and without Alzheimer's disease.
Across its clinical program, Solanezumab trials have enrolled a total of 1,169 patients. The studies were randomized, double blind, and placebo controlled. The largest trial, NCT02008357, enrolled 1,169 participants, while the Phase 2 DIAN-TU studies enrolled 194 and 490 participants respectively.