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LY450139 · 4 trials · 2 indications
The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
ADAS-Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
ADAS-Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
| Arm | Type | Description |
|---|---|---|
| LY450139 | EXPERIMENTAL | Participants received 60 milligrams (mg) LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88. |
| 100 mg LY450139 | EXPERIMENTAL | Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88. |
| 140 mg LY450139 | EXPERIMENTAL | Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88. |
| 1 | EXPERIMENTAL | 100 mg LY 450139 oral |
| 2 | EXPERIMENTAL | 140 mg LY450139 oral |
| 3 | EXPERIMENTAL | 280 mg LY450139 oral |
| 4 | EXPERIMENTAL | Placebo |
| Name | Type | Description |
|---|---|---|
| LY450139 | DRUG | Administered orally once daily. |
| Placebo | DRUG | Administered orally once daily. |
| LY450139 dihydrate | DRUG | - |
Inclusion Criteria: * Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination score of 16 through 26 at visit 1 * Modified Hachinski Ischemia Scale score of less than or equal to 4 * Geriatric Depression Scale score of less than or equal to 6 * A magnetic res...
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LY450139 is an investigational small molecule being studied for the treatment of Alzheimer's disease. It has been evaluated in clinical trials for mild to moderate Alzheimer's disease and for long-term progression of the disease. The drug is still in clinical development and has not been approved by regulatory authorities.
LY450139 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company has sponsored clinical trials of this investigational drug in patients with Alzheimer's disease.
LY450139 has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. All trials listed are completed, with no active trials currently ongoing. The drug remains investigational and has not received regulatory approval for any indication.
LY450139 has been studied in several completed trials, including NCT00244322 (Phase 2, mild to moderate Alzheimer's disease), NCT00594568 (Phase 3, long-term progression), NCT00762411 (Phase 3, progression compared with placebo), and NCT00765115 (Phase 1, healthy subjects). These trials enrolled a total of 2,693 participants.
LY450139 is also known as semagacestat, a gamma-secretase inhibitor developed by Eli Lilly for Alzheimer's disease. The drug was investigated in multiple clinical trials but did not demonstrate benefit and was discontinued. It is not approved for use.