Phase 3
Completed N=180
A Study of Semagacestat for Alzheimer's Patients
Source: ClinicalTrials.gov NCT01035138 ↗Enrolled (actual)
180
Serious AEs
6.7%
Results posted
Sep 2014
Primary outcomePrimary: Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug — 6.4; 12.5; 10.5 units on a scale
Summary
The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF).
Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug |
6.4; 12.5; 10.5 | — |
| PRIMARY Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug |
-4.5; -10.6; -5.1 | — |
| SECONDARY Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12 |
-5.84; -6.09; 14.27 | — |
| SECONDARY Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12 |
-115.39; -279.29; 22.49; -141.79; -187.16; -3.86 | — |
| SECONDARY Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12 |
— | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12 |
9.3; 8.06; 11.56 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12 |
10.35; 9.09; 12.66 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12 |
11.31; 10.02; 14.50 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12 |
-12.34; -8.22; -8.74 | — |
| SECONDARY Mean Concentration of LY450139 |
1.81; 1160; 679; 341 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug |
6.7; 12.6; 11.2 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug |
7.7; 14.1; 13.3 | — |
| SECONDARY Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24 |
4.18; 2.99; 3.39 | — |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24 |
-4.67; -4.15; -4.84 | — |
| SECONDARY Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24 |
1.87; 1.94; 3.62 | — |
| SECONDARY Change From Baseline in EuroQol-5D (EQ-5D) at Week 24 |
0.76; -2.23; -14.44 | — |
| SECONDARY Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12 |
1.80; 0.67; 0.33 | — |
Eligibility Criteria
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 have a reliable caregiver
- Capable of swallowing whole oral medication
- Agrees not to participate in other investigational compounds for the duration of study
Exclusion Criteria
- Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study
Data sourced from ClinicalTrials.gov (NCT01035138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.