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Also known as LY450139 dihydrate, Semagacestat
LY450139 · 5 trials · 2 indications
The cognitive subscale of the 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.
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
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 |
|---|---|---|
| Drug: semagacestat | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| semagacestat | DRUG | 140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability |
| LY450139 | DRUG | Administered orally once daily. |
| Placebo | DRUG | Administered orally once daily. |
| LY450139 dihydrate | DRUG | - |
Inclusion Criteria: * Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease * Completed semagacestat study LFAN or study LFBC through 88 weeks * Must continue to ...
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LY450139 is an investigational small molecule developed by Eli Lilly and Company for Alzheimer disease. It was studied in Phase 3 clinical development as a potential treatment for the condition. All four of its registered clinical trials have been completed, and no trials are currently active.
LY450139 was developed as a treatment for Alzheimer disease. It was evaluated in Phase 2 and Phase 3 clinical trials involving patients with mild to moderate Alzheimer disease, as well as in a Phase 1 study of healthy volunteers. It is an investigational agent and is not an approved therapy.
LY450139 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly sponsored all four registered clinical trials of the compound, including the Phase 3 studies conducted across North America, Europe, Asia, and South America.
LY450139 reached Phase 3 clinical development. Two Phase 3 trials were conducted: NCT00762411, which enrolled 1,111 participants, and NCT00594568, which enrolled 1,537 participants. Both Phase 3 studies and the earlier Phase 1 and Phase 2 trials have been completed, and no trials are currently active.
LY450139 has been studied in four completed clinical trials. These include the Phase 1 study NCT00765115, the Phase 2 study NCT00244322, and the Phase 3 studies NCT00762411 and NCT00594568. Together these trials enrolled approximately 2,720 participants, with the Phase 3 studies using randomized, double-blind, controlled designs.
Yes, LY450139 dihydrate is an alternative name for LY450139. The dihydrate form was used in the Phase 2 trial NCT00244322, titled Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease. Searches for either name refer to the same Eli Lilly compound.