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Also known as LY450139
semagacestat · 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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Semagacestat was developed for the treatment of Alzheimer's disease. It is an investigational small molecule that was studied in a Phase 3 clinical trial in patients with Alzheimer's disease. It is not an approved therapy.
Semagacestat is an inhibitor that targets the gamma-secretase complex components APH1A, PSENEN, APH1B, PSEN1, NCSTN, and PSEN2. By inhibiting these proteins, it was intended to interfere with the gamma-secretase enzyme complex.
Semagacestat was developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the clinical trial of semagacestat in Alzheimer's disease.
Semagacestat reached Phase 3 clinical development for Alzheimer's disease. The Phase 3 trial has been completed. Semagacestat is investigational and has not been approved by the FDA.
Semagacestat was studied in one Phase 3 clinical trial, NCT01035138, titled A Study of Semagacestat for Alzheimer's Patients. The trial enrolled 180 participants, was uncontrolled, and has been completed. It took place in the United States, Australia, Canada, Chile, Finland, France, Germany, Israel, Italy, Japan, Poland, South Africa, Spain, and Sweden.