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semagacestat

Phase 3

Alzheimer's Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Sep 25, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

semagacestat · 1 trial · 1 indication

Phase 3 1
NCT01035138A Study of Semagacestat for Alzheimer's PatientsAlzheimer's Disease
COMPLETED180 Analytics
PHASE3COMPLETED
A Study of Semagacestat for Alzheimer's Patients
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

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.

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

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.

Secondary Endpoints

Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12
Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12
Baseline (LFAN Randomization), 12 weeks (LFBF)
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12
Baseline (LFAN Randomization), 12 weeks (LFBF)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug: semagacestatEXPERIMENTAL -

Interventions

NameTypeDescription
semagacestatDRUG140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites71

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 ...

Countries:United StatesAustraliaCanadaChileFinlandFranceGermanyIsraelItalyJapanPolandSouth AfricaSpainSweden
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Frequently asked questions about semagacestat

What is semagacestat used for?

Semagacestat is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is being developed by Eli Lilly and Company (LLY) and has completed a Phase 3 clinical trial. The drug is not approved and remains in clinical development.

Who makes semagacestat?

Semagacestat is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule intended for Alzheimer's Disease.

What phase is semagacestat in?

Semagacestat has completed a Phase 3 clinical trial for Alzheimer's Disease. The trial, NCT01035138, was a completed, uncontrolled study with 180 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is semagacestat in?

Semagacestat has one completed Phase 3 clinical trial, NCT01035138, titled 'A Study of Semagacestat for Alzheimer's Patients'. The trial enrolled 180 participants across multiple countries including the United States, Australia, Canada, Chile, Finland, France, Germany, Israel, Italy, Japan, Poland, South Africa, Spain, and Sweden.

Is semagacestat FDA approved?

Semagacestat is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial for Alzheimer's Disease. The trial, NCT01035138, was completed, but the drug remains in clinical development and has not been approved for any use.