Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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)
Query!
Secondary ID [1]
0
0
H6L-MC-LFBF
Query!
Secondary ID [2]
0
0
5930
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Identity XT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Alzheimer's disease
Query!
Neurological
0
0
0
0
Query!
Dementias
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
Query!
Secondary outcome [1]
0
0
Percent Change From Baseline in Amyloid Beta (Aß) 1-42 Plasma Concentration at Week 12
Query!
Assessment method [1]
0
0
Concentration of amino acid peptide known as Aß 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [1]
0
0
Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
Query!
Secondary outcome [2]
0
0
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12
Query!
Assessment method [2]
0
0
The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [2]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
Secondary outcome [3]
0
0
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12
Query!
Assessment method [3]
0
0
A radioactive tracer for PET that is a ligand for amyloid called \[18F\]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.
Query!
Timepoint [3]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
Secondary outcome [4]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12
Query!
Assessment method [4]
0
0
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. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [4]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
Secondary outcome [5]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12
Query!
Assessment method [5]
0
0
ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [5]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
Secondary outcome [6]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12
Query!
Assessment method [6]
0
0
The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [6]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
Secondary outcome [7]
0
0
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12
Query!
Assessment method [7]
0
0
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. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [7]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
Secondary outcome [8]
0
0
Mean Concentration of LY450139
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
Query!
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
Query!
Assessment method [9]
0
0
ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.
Query!
Timepoint [9]
0
0
Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
Query!
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
Query!
Assessment method [10]
0
0
The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity.
Query!
Timepoint [10]
0
0
Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
Query!
Secondary outcome [11]
0
0
Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24
Query!
Assessment method [11]
0
0
The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [11]
0
0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Query!
Secondary outcome [12]
0
0
Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24
Query!
Assessment method [12]
0
0
The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [12]
0
0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Query!
Secondary outcome [13]
0
0
Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24
Query!
Assessment method [13]
0
0
The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.
Query!
Timepoint [13]
0
0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Query!
Secondary outcome [14]
0
0
Change From Baseline in EuroQol-5D (EQ-5D) at Week 24
Query!
Assessment method [14]
0
0
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.
Query!
Timepoint [14]
0
0
Baseline (LFAN Randomization), 24 weeks (LFBF)
Query!
Secondary outcome [15]
0
0
Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12
Query!
Assessment method [15]
0
0
RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.
Query!
Timepoint [15]
0
0
Baseline (LFAN Randomization), 12 weeks (LFBF)
Query!
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
Query!
Minimum age
55
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
180
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
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
Query!
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
Query!
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
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [3]
0
0
3081 - Heidelberg West
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oklahoma
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oregon
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Rhode Island
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Vermont
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
British Columbia
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Quebec
Query!
Country [22]
0
0
Chile
Query!
State/province [22]
0
0
Antofagasta
Query!
Country [23]
0
0
Chile
Query!
State/province [23]
0
0
Santiago
Query!
Country [24]
0
0
Chile
Query!
State/province [24]
0
0
Valdivia
Query!
Country [25]
0
0
Finland
Query!
State/province [25]
0
0
Kuopio
Query!
Country [26]
0
0
Finland
Query!
State/province [26]
0
0
Oulu
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Toulouse
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Hannover
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Muenchen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Regensburg
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Siegen
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Ashkelon
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Petah Tikva
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Tel Hashomer
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Milano
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Fukui
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Fukuoka
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Kochi
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Tokushima
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Lublin
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Poznan
Query!
Country [42]
0
0
South Africa
Query!
State/province [42]
0
0
Bellville
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Barcelona
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Plasencia
Query!
Country [45]
0
0
Sweden
Query!
State/province [45]
0
0
Stockholm
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01035138
Query!
Trial related presentations / publications
Query!
Public notes
Query!
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01035138
Download to PDF