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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01035138




Registration number
NCT01035138
Ethics application status
Date submitted
17/12/2009
Date registered
18/12/2009
Date last updated
25/09/2014

Titles & IDs
Public title
A Study of Semagacestat for Alzheimer's Patients
Scientific title
Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)
Secondary ID [1] 0 0
H6L-MC-LFBF
Secondary ID [2] 0 0
5930
Universal Trial Number (UTN)
Trial acronym
Identity XT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - semagacestat

Experimental: Drug: semagacestat -


Treatment: Drugs: semagacestat
140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug
Timepoint [1] 0 0
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
Primary outcome [2] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug
Timepoint [2] 0 0
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
Secondary outcome [1] 0 0
Percent Change From Baseline in Amyloid Beta (Aß) 1-42 Plasma Concentration at Week 12
Timepoint [1] 0 0
Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
Secondary outcome [2] 0 0
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12
Timepoint [2] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Secondary outcome [3] 0 0
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12
Timepoint [3] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Secondary outcome [4] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12
Timepoint [4] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Secondary outcome [5] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12
Timepoint [5] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Secondary outcome [6] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12
Timepoint [6] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Secondary outcome [7] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12
Timepoint [7] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Secondary outcome [8] 0 0
Mean Concentration of LY450139
Timepoint [8] 0 0
3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
Secondary outcome [9] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug
Timepoint [9] 0 0
Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
Secondary outcome [10] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug
Timepoint [10] 0 0
Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
Secondary outcome [11] 0 0
Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24
Timepoint [11] 0 0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Secondary outcome [12] 0 0
Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24
Timepoint [12] 0 0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Secondary outcome [13] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24
Timepoint [13] 0 0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Secondary outcome [14] 0 0
Change From Baseline in EuroQol-5D (EQ-5D) at Week 24
Timepoint [14] 0 0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Secondary outcome [15] 0 0
Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12
Timepoint [15] 0 0
Baseline (LFAN Randomization), 12 weeks (LFBF)

Eligibility
Key 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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kogarah
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Geelong
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg West
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
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Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
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Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Chile
State/province [22] 0 0
Antofagasta
Country [23] 0 0
Chile
State/province [23] 0 0
Santiago
Country [24] 0 0
Chile
State/province [24] 0 0
Valdivia
Country [25] 0 0
Finland
State/province [25] 0 0
Kuopio
Country [26] 0 0
Finland
State/province [26] 0 0
Oulu
Country [27] 0 0
France
State/province [27] 0 0
Toulouse
Country [28] 0 0
Germany
State/province [28] 0 0
Hannover
Country [29] 0 0
Germany
State/province [29] 0 0
Muenchen
Country [30] 0 0
Germany
State/province [30] 0 0
Regensburg
Country [31] 0 0
Germany
State/province [31] 0 0
Siegen
Country [32] 0 0
Israel
State/province [32] 0 0
Ashkelon
Country [33] 0 0
Israel
State/province [33] 0 0
Petah Tikva
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Hashomer
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Japan
State/province [36] 0 0
Fukui
Country [37] 0 0
Japan
State/province [37] 0 0
Fukuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Kochi
Country [39] 0 0
Japan
State/province [39] 0 0
Tokushima
Country [40] 0 0
Poland
State/province [40] 0 0
Lublin
Country [41] 0 0
Poland
State/province [41] 0 0
Poznan
Country [42] 0 0
South Africa
State/province [42] 0 0
Bellville
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Plasencia
Country [45] 0 0
Sweden
State/province [45] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01035138
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01035138