Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Solanezumab · 3 trials · 2 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.
| 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). |
| 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 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered IV |
| Solanezumab | DRUG | Administered IV |
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 drug being studied for Alzheimer's disease and cognition disorders. It is a monoclonal antibody developed by Eli Lilly and Company. Clinical trials have evaluated it in patients with Alzheimer's disease and in older individuals at risk for memory loss. It is not approved and remains in clinical development.
Solanezumab is a monoclonal antibody, classified as a -mab, that targets amyloid beta protein. It is designed to bind to amyloid beta, which is believed to play a role in Alzheimer's disease. The drug is being studied for its potential effects on cognition and Alzheimer's-related pathology.
Solanezumab is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. Eli Lilly has sponsored clinical trials of solanezumab in patients with Alzheimer's disease and cognition disorders across multiple countries.
Solanezumab has completed Phase 3 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, NCT02008357, evaluated solanezumab in older individuals at risk for memory loss. Earlier Phase 2 trials have also been completed.
Solanezumab has been studied in three completed clinical trials. NCT02008357 was a Phase 3 trial in older individuals at risk for memory loss. NCT00749216 was a Phase 2 safety study in Japanese patients with Alzheimer's disease. NCT01148498 was a Phase 2 biomarker study in patients with and without Alzheimer's.
Solanezumab is a distinct monoclonal antibody developed by Eli Lilly. It is not the same as other Alzheimer's drugs, as it specifically targets amyloid beta. Its mechanism and clinical development are unique, and it has been studied in trials for Alzheimer's disease and cognition disorders.