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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Effect of ?-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo
Secondary ID [1] 0 0
H6L-MC-LFAN
Secondary ID [2] 0 0
7666
Universal Trial Number (UTN)
Trial acronym
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 - 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
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) Score at 76 Weeks
Timepoint [1] 0 0
Baseline (randomization), 76 weeks
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
Timepoint [2] 0 0
Baseline (randomization), 16 weeks following treatment cessation
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
Timepoint [3] 0 0
Baseline (randomization), 76 weeks
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
Timepoint [4] 0 0
Baseline (randomization), 16 weeks following treatment cessation
Secondary outcome [1] 0 0
Percent Change From Baseline in Amyloid Beta (Aß) 1-42 Plasma Concentration at 52 Weeks
Timepoint [1] 0 0
Baseline (randomization), 52 weeks
Secondary outcome [2] 0 0
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Timepoint [2] 0 0
Baseline (randomization), 76 weeks
Secondary outcome [3] 0 0
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
Timepoint [3] 0 0
Baseline (randomization), up to 76 weeks
Secondary outcome [4] 0 0
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
Timepoint [4] 0 0
Baseline (randomization), up to 76 weeks
Secondary outcome [5] 0 0
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Timepoint [5] 0 0
Baseline (randomization), up to 76 weeks
Secondary outcome [6] 0 0
LY450139 Population Pharmacokinetics: Clearance of LY450139
Timepoint [6] 0 0
6 weeks, 12 weeks, and 52 weeks
Secondary outcome [7] 0 0
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Timepoint [7] 0 0
6 weeks, 12 weeks, and 52 weeks
Secondary outcome [8] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks
Timepoint [8] 0 0
Baseline (randomization), 76 weeks
Secondary outcome [9] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks
Timepoint [9] 0 0
Baseline (randomization), 76 weeks
Secondary outcome [10] 0 0
Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks
Timepoint [10] 0 0
Baseline (randomization), 76 weeks
Secondary outcome [11] 0 0
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks
Timepoint [11] 0 0
Baseline (randomization), 76 weeks
Secondary outcome [12] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks
Timepoint [12] 0 0
Baseline (randomization), 76 weeks
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
Timepoint [13] 0 0
Baseline (randomization), 76 weeks
Secondary outcome [14] 0 0
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks
Timepoint [14] 0 0
Baseline (randomization), up to 76 weeks
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
Timepoint [15] 0 0
Baseline (randomization), 16 weeks following treatment cessation
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
Timepoint [16] 0 0
Baseline (randomization), 16 weeks following treatment cessation
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
Timepoint [17] 0 0
Baseline (randomization), 4 weeks following treatment cessation
Secondary outcome [18] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug
Timepoint [18] 0 0
Baseline (randomization), 4 weeks following treatment cessation
Secondary outcome [19] 0 0
Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug
Timepoint [19] 0 0
Baseline (randomization), 4 weeks following treatment cessation
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
Timepoint [20] 0 0
Baseline (randomization), 4 weeks following treatment cessation
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
Timepoint [21] 0 0
Baseline (randomization), 4 weeks following treatment cessation
Secondary outcome [22] 0 0
Change From Baseline in Amyloid Beta (Aß) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Timepoint [22] 0 0
Baseline (randomization), up to 76 weeks
Secondary outcome [23] 0 0
Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid
Timepoint [23] 0 0
Baseline (randomization), up to 76 weeks

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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
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
Intervention assignment
Parallel
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
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
1537
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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
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
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
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
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
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
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
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
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2013 - Randwick, Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [7] 0 0
3101 - Kew
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
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Indiana
Country [9] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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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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Utah
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Vermont
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Wisconsin
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Argentina
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Buenos Aires
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Cordoba
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Santa Fe
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Aalst
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Antwerp
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Brugge
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Leuven
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Concepcion
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Mangalore
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Mumbai
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Thiruvananthapuram
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Tirupati
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Ashkelon
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Haifa
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Tel Aviv
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Tel Hashomer
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Pisa
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Fukuoka
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Kagawa
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Kochi
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Osaka
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Bellville
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Cape Town
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George
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Rosebank
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Somerset West
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Umhlanga
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Albacete
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Barakaldo
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Madrid
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Malmo
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Stockholm
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Uddevalla
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Banes
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Belfast
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Newcastle
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United Kingdom
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Stoke-On-Trent

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00594568