Alzheimer's Disease
Conditions
Interventions
Product Name: Semagacestat
Product Code: LY450139
Pharmaceutical Form: Tablet
INN or Proposed INN: Semagacestat
Current Sponsor code: LY450139
Other descriptive name: Semagacestat
Concentration unit:
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient included in the study must meet all of the following inclusion criteria. [1] Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD. [2] Has completed semagacestat Study LFAN or Study LFBC through Visit 20. [3] Must continue to have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications. Note: The caregiver must be able to communicate with site personnel and be willing to comply with protocol requirements, and in the investigator’s opinion must have adequate literacy to complete the protocol-specified questionnaires. Participants living in an assisted-living facility may be included if study medication intake is supervised and if regular contact with a caregiver who accompanies the patient is maintained. [4] Must be capable of swallowing whole oral medications. [5] Agrees not to participate in studies of any other investigational compounds for the duration of Study LFBF. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [6] Meets feeder study discontinuation criteria at the last visit of the feeder study (Study LFBF Visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the safety of semagacestat in Alzheimer’s disease patients during 24 months of open-label treatment following completion of up to 21 months of active treatment in a double-blind registration study (LFAN or LFBC) through analysis of AEs, vital signs, laboratory evaluations, and electrocardiograms (ECGs).;Secondary Objective: • To test the hypothesis that semagacestat will continue to slow the cognitive and functional decline associated with AD during 24 months of open-label treatment, comparing patients treated with semagacestat for = 6 months with patients treated for 21 months in the feeder studies (LFAN or LFBC). • To assess the overall clinical benefit of treatment with semagacestat in AD patients during 24 months of open-label treatment, comparing patients treated with semagacestat for = 6 months with patients treated for 21 months in the feeder studies (LFAN or LFBC). • To provide supporting evidence that semagacestat slows the progression of disease, multiple biomarkers are being assessed in Studies LFAN and LFBC. For further secondary objectives please see protocol;Primary end point(s): Completion of 24 month treatment period | — |
Countries
Belgium, Finland, France, Germany, Italy, Spain, Sweden
Outcome results
None listed