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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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H6L-MC-LFBF
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Secondary ID [2]
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5930
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Universal Trial Number (UTN)
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Trial acronym
Identity XT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
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Primary outcome [2]
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Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
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Secondary outcome [1]
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Percent Change From Baseline in Amyloid Beta (Aß) 1-42 Plasma Concentration at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
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Secondary outcome [2]
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Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Secondary outcome [3]
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Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Secondary outcome [4]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Secondary outcome [5]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Secondary outcome [6]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Secondary outcome [7]
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Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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Secondary outcome [8]
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Mean Concentration of LY450139
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Assessment method [8]
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Timepoint [8]
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3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
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Secondary outcome [9]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
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Secondary outcome [10]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
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Secondary outcome [11]
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Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Secondary outcome [12]
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Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Secondary outcome [13]
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Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Secondary outcome [14]
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Change From Baseline in EuroQol-5D (EQ-5D) at Week 24
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline (LFAN Randomization), 24 weeks (LFBF)
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Secondary outcome [15]
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Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline (LFAN Randomization), 12 weeks (LFBF)
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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
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or
LFBC study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2011
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Sample size
Target
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Accrual to date
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Final
180
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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3081 - Heidelberg West
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Indiana
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Kentucky
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United States of America
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Louisiana
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Massachusetts
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Missouri
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Vermont
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Canada
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British Columbia
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Canada
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Quebec
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Chile
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Antofagasta
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Chile
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Santiago
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Chile
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Valdivia
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Finland
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Kuopio
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Finland
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Oulu
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France
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Toulouse
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Germany
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Hannover
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Germany
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Muenchen
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Germany
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Regensburg
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Germany
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Siegen
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Israel
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Ashkelon
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Israel
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Petah Tikva
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Israel
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Tel Hashomer
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Italy
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Milano
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Japan
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Fukui
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Japan
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Fukuoka
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Japan
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Kochi
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Japan
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Tokushima
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Poland
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Lublin
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Poland
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Poznan
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South Africa
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Bellville
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Spain
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Barcelona
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Spain
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Plasencia
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Sweden
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01035138
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01035138
Download to PDF