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 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/ct2/show/NCT00594568
Registration number
NCT00594568
Ethics application status
Date submitted
11/01/2008
Date registered
15/01/2008
Date last updated
17/03/2015
Titles & IDs
Public title
Effect of LY450139 on the Long Term Progression of Alzheimer's Disease
Query!
Scientific title
Effect of ?-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo
Query!
Secondary ID [1]
0
0
H6L-MC-LFAN
Query!
Secondary ID [2]
0
0
7666
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
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 - LY450139
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
Experimental: 100 mg LY450139 - Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Experimental: 140 mg LY450139 - Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Treatment: Drugs: LY450139
Administered orally once daily
Treatment: Drugs: Placebo
Administered orally once daily
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) Score at 76 Weeks
Query!
Assessment method [1]
0
0
ADAS-Cog11 was used as a primary efficacy measure. It 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 Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [1]
0
0
Baseline (randomization), 76 weeks
Query!
Primary outcome [2]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug
Query!
Assessment method [2]
0
0
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 Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [2]
0
0
Baseline (randomization), 16 weeks following treatment cessation
Query!
Primary outcome [3]
0
0
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks
Query!
Assessment method [3]
0
0
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [3]
0
0
Baseline (randomization), 76 weeks
Query!
Primary outcome [4]
0
0
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug
Query!
Assessment method [4]
0
0
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [4]
0
0
Baseline (randomization), 16 weeks following treatment cessation
Query!
Secondary outcome [1]
0
0
Percent Change From Baseline in Amyloid Beta (Aß) 1-42 Plasma Concentration at 52 Weeks
Query!
Assessment method [1]
0
0
Concentration of amino acid peptide, known as Aß 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [1]
0
0
Baseline (randomization), 52 weeks
Query!
Secondary outcome [2]
0
0
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Query!
Assessment method [2]
0
0
Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [2]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [3]
0
0
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
Query!
Assessment method [3]
0
0
The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [3]
0
0
Baseline (randomization), up to 76 weeks
Query!
Secondary outcome [4]
0
0
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
Query!
Assessment method [4]
0
0
A radioactive tracer for PET that is a ligand for amyloid called 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 (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [4]
0
0
Baseline (randomization), up to 76 weeks
Query!
Secondary outcome [5]
0
0
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Query!
Assessment method [5]
0
0
Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [5]
0
0
Baseline (randomization), up to 76 weeks
Query!
Secondary outcome [6]
0
0
LY450139 Population Pharmacokinetics: Clearance of LY450139
Query!
Assessment method [6]
0
0
Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.
Query!
Timepoint [6]
0
0
6 weeks, 12 weeks, and 52 weeks
Query!
Secondary outcome [7]
0
0
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Query!
Assessment method [7]
0
0
Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.
Query!
Timepoint [7]
0
0
6 weeks, 12 weeks, and 52 weeks
Query!
Secondary outcome [8]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks
Query!
Assessment method [8]
0
0
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [8]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [9]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks
Query!
Assessment method [9]
0
0
ADAS-Cog14 is 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 Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
Query!
Timepoint [9]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [10]
0
0
Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks
Query!
Assessment method [10]
0
0
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [10]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [11]
0
0
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks
Query!
Assessment method [11]
0
0
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [11]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [12]
0
0
Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks
Query!
Assessment method [12]
0
0
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [12]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [13]
0
0
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks
Query!
Assessment method [13]
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. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [13]
0
0
Baseline (randomization), 76 weeks
Query!
Secondary outcome [14]
0
0
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks
Query!
Assessment method [14]
0
0
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.
Query!
Timepoint [14]
0
0
Baseline (randomization), up to 76 weeks
Query!
Secondary outcome [15]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug
Query!
Assessment method [15]
0
0
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Query!
Timepoint [15]
0
0
Baseline (randomization), 16 weeks following treatment cessation
Query!
Secondary outcome [16]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug
Query!
Assessment method [16]
0
0
ADAS-Cog14 is 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 Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
Query!
Timepoint [16]
0
0
Baseline (randomization), 16 weeks following treatment cessation
Query!
Secondary outcome [17]
0
0
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug
Query!
Assessment method [17]
0
0
Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.
Query!
Timepoint [17]
0
0
Baseline (randomization), 4 weeks following treatment cessation
Query!
Secondary outcome [18]
0
0
Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug
Query!
Assessment method [18]
0
0
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed
Query!
Timepoint [18]
0
0
Baseline (randomization), 4 weeks following treatment cessation
Query!
Secondary outcome [19]
0
0
Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug
Query!
Assessment method [19]
0
0
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.
Query!
Timepoint [19]
0
0
Baseline (randomization), 4 weeks following treatment cessation
Query!
Secondary outcome [20]
0
0
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug
Query!
Assessment method [20]
0
0
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.
Query!
Timepoint [20]
0
0
Baseline (randomization), 4 weeks following treatment cessation
Query!
Secondary outcome [21]
0
0
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug
Query!
Assessment method [21]
0
0
RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.
Query!
Timepoint [21]
0
0
Baseline (randomization), 4 weeks following treatment cessation
Query!
Secondary outcome [22]
0
0
Change From Baseline in Amyloid Beta (Aß) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Query!
Assessment method [22]
0
0
Concentration of an amino peptide known as Aß 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [22]
0
0
Baseline (randomization), up to 76 weeks
Query!
Secondary outcome [23]
0
0
Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid
Query!
Assessment method [23]
0
0
Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Query!
Timepoint [23]
0
0
Baseline (randomization), up to 76 weeks
Query!
Eligibility
Key inclusion criteria
- Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State
Examination (MMSE) score of 16-26 at Visit 1
- Modified Hachinski Ischemia Scale score of less than or equal to 4
- Geriatric Depression Scale score of less than or equal to 6
- A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2
years with no findings inconsistent with a diagnosis of AD
- If female, must be without menstruation for at least 12 consecutive months or have had
both ovaries removed
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
- Is not capable of swallowing whole oral medication
- Has serious or unstable illnesses
- Does not have a reliable caregiver
- Chronic alcohol or drug abuse within the past 5 years
- Has ever had active vaccination for AD
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
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
1/03/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1537
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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. - Hornsby
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. - Kogarah
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. - Randwick, Sydney
Query!
Recruitment hospital [4]
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. - Adelaide
Query!
Recruitment hospital [5]
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 [6]
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 hospital [7]
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. - Kew
Query!
Recruitment hospital [8]
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. - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2077 - Hornsby
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
2013 - Randwick, Sydney
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [6]
0
0
3081 - Heidelberg West
Query!
Recruitment postcode(s) [7]
0
0
3101 - Kew
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oregon
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Rhode Island
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Vermont
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Wisconsin
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Buenos Aires
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Cordoba
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Santa Fe
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Aalst
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Antwerp
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brugge
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Leuven
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
British Columbia
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Quebec
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Antofagasta
Query!
Country [35]
0
0
Chile
Query!
State/province [35]
0
0
Concepcion
Query!
Country [36]
0
0
Chile
Query!
State/province [36]
0
0
Santiago De Chile
Query!
Country [37]
0
0
Chile
Query!
State/province [37]
0
0
Santiago
Query!
Country [38]
0
0
Chile
Query!
State/province [38]
0
0
Valdivia
Query!
Country [39]
0
0
Chile
Query!
State/province [39]
0
0
Vina Del Mar
Query!
Country [40]
0
0
Denmark
Query!
State/province [40]
0
0
Kobenhavn
Query!
Country [41]
0
0
Denmark
Query!
State/province [41]
0
0
Roskilde
Query!
Country [42]
0
0
Denmark
Query!
State/province [42]
0
0
Svendborg
Query!
Country [43]
0
0
Finland
Query!
State/province [43]
0
0
Kuopio
Query!
Country [44]
0
0
Finland
Query!
State/province [44]
0
0
Mikkeli
Query!
Country [45]
0
0
Finland
Query!
State/province [45]
0
0
Oulu
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Nice
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Rennes
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Rouen
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Toulouse
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Tours
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Dresden
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Goettingen
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Hannover
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Muenchen
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Regensburg
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Siegen
Query!
Country [57]
0
0
India
Query!
State/province [57]
0
0
Chennai
Query!
Country [58]
0
0
India
Query!
State/province [58]
0
0
Hyderabaad
Query!
Country [59]
0
0
India
Query!
State/province [59]
0
0
Kolkatta
Query!
Country [60]
0
0
India
Query!
State/province [60]
0
0
Mangalore
Query!
Country [61]
0
0
India
Query!
State/province [61]
0
0
Mumbai
Query!
Country [62]
0
0
India
Query!
State/province [62]
0
0
Thiruvananthapuram
Query!
Country [63]
0
0
India
Query!
State/province [63]
0
0
Tirupati
Query!
Country [64]
0
0
India
Query!
State/province [64]
0
0
Varanasi
Query!
Country [65]
0
0
Israel
Query!
State/province [65]
0
0
Ashkelon
Query!
Country [66]
0
0
Israel
Query!
State/province [66]
0
0
Beer Sheva
Query!
Country [67]
0
0
Israel
Query!
State/province [67]
0
0
Haifa
Query!
Country [68]
0
0
Israel
Query!
State/province [68]
0
0
Jerusalem
Query!
Country [69]
0
0
Israel
Query!
State/province [69]
0
0
Petah Tikva
Query!
Country [70]
0
0
Israel
Query!
State/province [70]
0
0
Tel Aviv
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Tel Hashomer
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Milano
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Pisa
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Rome
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Fukui
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Fukuoka
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Kagawa
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Kochi
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Osaka
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Tokushima
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Bialystok
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Gdynia
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Lodz
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Lublin
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Poznan
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Warsaw
Query!
Country [87]
0
0
South Africa
Query!
State/province [87]
0
0
Bellair
Query!
Country [88]
0
0
South Africa
Query!
State/province [88]
0
0
Bellville
Query!
Country [89]
0
0
South Africa
Query!
State/province [89]
0
0
Cape Town
Query!
Country [90]
0
0
South Africa
Query!
State/province [90]
0
0
George
Query!
Country [91]
0
0
South Africa
Query!
State/province [91]
0
0
Johannesburg
Query!
Country [92]
0
0
South Africa
Query!
State/province [92]
0
0
Rosebank
Query!
Country [93]
0
0
South Africa
Query!
State/province [93]
0
0
Somerset West
Query!
Country [94]
0
0
South Africa
Query!
State/province [94]
0
0
Umhlanga
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
Albacete
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Barakaldo
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Barcelona
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Madrid
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Plasencia
Query!
Country [100]
0
0
Sweden
Query!
State/province [100]
0
0
Malmo
Query!
Country [101]
0
0
Sweden
Query!
State/province [101]
0
0
Molndal
Query!
Country [102]
0
0
Sweden
Query!
State/province [102]
0
0
Norrköping
Query!
Country [103]
0
0
Sweden
Query!
State/province [103]
0
0
Stockholm
Query!
Country [104]
0
0
Sweden
Query!
State/province [104]
0
0
Uddevalla
Query!
Country [105]
0
0
United Kingdom
Query!
State/province [105]
0
0
Banes
Query!
Country [106]
0
0
United Kingdom
Query!
State/province [106]
0
0
Hants
Query!
Country [107]
0
0
United Kingdom
Query!
State/province [107]
0
0
Merseyside
Query!
Country [108]
0
0
United Kingdom
Query!
State/province [108]
0
0
Scotland
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
Wilts
Query!
Country [110]
0
0
United Kingdom
Query!
State/province [110]
0
0
Belfast
Query!
Country [111]
0
0
United Kingdom
Query!
State/province [111]
0
0
Newcastle
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
Stoke-On-Trent
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
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no
cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid
(ß-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD
patients are required to have these amyloid plaques in the brain in order to have a
definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (?-secretase) lowers the
production of ß-amyloid. Semagacestat (LY450139) is a functional ?-secretase inhibitor and
was shown to lower ß-amyloid in blood and spinal fluid in humans tested thus far and in
blood, spinal fluid, and brain in animals tested thus far. This study used several different
tests to measure the effect of semagacestat on both ß-amyloid and amyloid plaques for some
participants. The build-up of amyloid plaques was measured by a brain scan that takes a
picture of amyloid plaques in the brain. Other tests measured the overall function of the
brain and brain size in some participants. In this trial, participants who initially received
placebo (inactive sugar pill) were, at a certain point in the study, switched over to active
drug, semagacestat. In other words, all participants could eventually receive active drug.
Participation could last approximately 2 years. Participants taking approved AD medications
were permitted to participate in this study and continue taking these medications during the
study. All participants who completed this study had the option to continue receiving
semagacestat by participating in an open-label study.
Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study
(H6L-MC-LFBC [LFBC; NCT00762411]) 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
open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data,
including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will
reflect results of analyses from the original LFAN protocol in addition to those from the
amended LFAN protocol.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00594568
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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00594568
Download to PDF