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Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY450139

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

100 mg LY450139

140 mg LY450139

Arm Description

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.

Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks

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.

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug

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.

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks

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.

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

Secondary Outcome Measures

Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks

Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks

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.

Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks

The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks

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.

Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks

Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

LY450139 Population Pharmacokinetics: Clearance of LY450139

Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.

LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139

Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks

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.

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks

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.

Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks

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.

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks

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.

Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks

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.

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

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.

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks

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.

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug

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.

Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug

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

Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug

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.

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

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.

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug

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.

Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks

Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid

Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Full Information

NCT ID

NCT00594568

First Posted

January 11, 2008

Last Updated

March 13, 2015

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00594568

Brief Title

Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

Official Title

Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 (β-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 (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-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 β-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1537 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

100 mg LY450139

Arm Type

Experimental

Arm Description

Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.

Arm Title

140 mg LY450139

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

LY450139

Other Intervention Name(s)

semagacestat

Intervention Description

Administered orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally once daily

Primary Outcome Measure Information:

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 16 weeks following treatment cessation

Title

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

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

Description

Time Frame

Baseline (randomization), 16 weeks following treatment cessation

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks

Description

Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Time Frame

Baseline (randomization), 52 weeks

Title

Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks

Description

The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Time Frame

Baseline (randomization), up to 76 weeks

Title

Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks

Description

Time Frame

Baseline (randomization), up to 76 weeks

Title

Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks

Description

Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Time Frame

Baseline (randomization), up to 76 weeks

Title

LY450139 Population Pharmacokinetics: Clearance of LY450139

Description

Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.

Time Frame

6 weeks, 12 weeks, and 52 weeks

Title

LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139

Description

Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.

Time Frame

6 weeks, 12 weeks, and 52 weeks

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks

Description

Time Frame

Baseline (randomization), 76 weeks

Title

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

Description

Time Frame

Baseline (randomization), 76 weeks

Title

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks

Description

Time Frame

Baseline (randomization), up to 76 weeks

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 16 weeks following treatment cessation

Title

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 16 weeks following treatment cessation

Title

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 4 weeks following treatment cessation

Title

Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 4 weeks following treatment cessation

Title

Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 4 weeks following treatment cessation

Title

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

Description

Time Frame

Baseline (randomization), 4 weeks following treatment cessation

Title

Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug

Description

Time Frame

Baseline (randomization), 4 weeks following treatment cessation

Title

Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks

Description

Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Time Frame

Baseline (randomization), up to 76 weeks

Title

Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid

Description

Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Time Frame

Baseline (randomization), up to 76 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

Facility Name

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34613

Country

United States

Facility Name

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

City

St Petersburg

State/Province

Florida

ZIP/Postal Code

33716

Country

United States

Facility Name

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

City

Tampa Bay

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

City

West Yarmouth

State/Province

Massachusetts

ZIP/Postal Code

02673

Country

United States

Facility Name

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

Facility Name

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Facility Name

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5004AOA

Country

Argentina

Facility Name

City

Santa Fe

ZIP/Postal Code

S3000FWO

Country

Argentina

Facility Name

City

Hornsby

State/Province

New South Wales

ZIP/Postal Code

2077

Country

Australia

Facility Name

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

City

Randwick, Sydney

State/Province

New South Wales

ZIP/Postal Code

2013

Country

Australia

Facility Name

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

City

Kew

State/Province

Victoria

ZIP/Postal Code

3101

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

City

Antwerp

ZIP/Postal Code

2020

Country

Belgium

Facility Name

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y3G8

Country

Canada

Facility Name

City

Penticton

State/Province

British Columbia

ZIP/Postal Code

V2A5C8

Country

Canada

Facility Name

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H1Z1

Country

Canada

Facility Name

City

Quebec

ZIP/Postal Code

G1R 3X5

Country

Canada

Facility Name

City

Antofagasta

Country

Chile

Facility Name

City

Concepcion

Country

Chile

Facility Name

City

Santiago De Chile

ZIP/Postal Code

6640870

Country

Chile

Facility Name

City

Santiago

Country

Chile

Facility Name

City

Valdivia

Country

Chile

Facility Name

City

Vina Del Mar

Country

Chile

Facility Name

City

Kobenhavn

ZIP/Postal Code

2100

Country

Denmark

Facility Name

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

City

Svendborg

ZIP/Postal Code

4000

Country

Denmark

Facility Name

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

City

Mikkeli

ZIP/Postal Code

50100

Country

Finland

Facility Name

City

Oulu

ZIP/Postal Code

90229

Country

Finland

Facility Name

City

Nice

ZIP/Postal Code

06002

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

City

Rouen

ZIP/Postal Code

76036

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

Goettingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30559

Country

Germany

Facility Name

City

Muenchen

ZIP/Postal Code

BY 80336

Country

Germany

Facility Name

City

Regensburg

ZIP/Postal Code

D-93053

Country

Germany

Facility Name

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Facility Name

City

Chennai

ZIP/Postal Code

600003

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

400082

Country

India

Facility Name

City

Kolkatta

ZIP/Postal Code

700054

Country

India

Facility Name

City

Mangalore

ZIP/Postal Code

575002

Country

India

Facility Name

City

Mumbai

ZIP/Postal Code

400050

Country

India

Facility Name

City

Thiruvananthapuram

ZIP/Postal Code

695011

Country

India

Facility Name

City

Tirupati

ZIP/Postal Code

517507

Country

India

Facility Name

City

Varanasi

ZIP/Postal Code

221005

Country

India

Facility Name

City

Ashkelon

ZIP/Postal Code

78306

Country

Israel

Facility Name

City

Beer Sheva

ZIP/Postal Code

84170

Country

Israel

Facility Name

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

City

Jerusalem

ZIP/Postal Code

91240

Country

Israel

Facility Name

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52661

Country

Israel

Facility Name

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00153

Country

Italy

Facility Name

City

Fukui

ZIP/Postal Code

910-3113

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

770-8076

Country

Japan

Facility Name

City

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

City

Kochi

ZIP/Postal Code

780-0842

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

590-0018

Country

Japan

Facility Name

City

Tokushima

ZIP/Postal Code

770-8076

Country

Japan

Facility Name

City

Bialystok

ZIP/Postal Code

15402

Country

Poland

Facility Name

City

Gdynia

ZIP/Postal Code

81-361

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

92-216

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-950

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-606

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Bellair

ZIP/Postal Code

4094

Country

South Africa

Facility Name

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

City

George

ZIP/Postal Code

6529

Country

South Africa

Facility Name

City

Johannesburg

ZIP/Postal Code

1709

Country

South Africa

Facility Name

City

Rosebank

ZIP/Postal Code

2132

Country

South Africa

Facility Name

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

City

Umhlanga

ZIP/Postal Code

4319

Country

South Africa

Facility Name

City

Albacete

ZIP/Postal Code

2006

Country

Spain

Facility Name

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08014

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

City

Plasencia

ZIP/Postal Code

10600

Country

Spain

Facility Name

City

Malmo

ZIP/Postal Code

20502

Country

Sweden

Facility Name

City

Molndal

ZIP/Postal Code

43185

Country

Sweden

Facility Name

City

Norrköping

ZIP/Postal Code

60172

Country

Sweden

Facility Name

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

City

Uddevalla

ZIP/Postal Code

45180

Country

Sweden

Facility Name

City

Bath

State/Province

Banes

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

City

Southampton

State/Province

Hants

ZIP/Postal Code

SO30 3JB

Country

United Kingdom

Facility Name

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

City

Swindon

State/Province

Wilts

ZIP/Postal Code

SN1 4JU

Country

United Kingdom

Facility Name

City

Belfast

ZIP/Postal Code

BT9 7BL

Country

United Kingdom

Facility Name

City

Newcastle

ZIP/Postal Code

NE4 6BE

Country

United Kingdom

Facility Name

City

Stoke-On-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26402769

Citation

Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

Results Reference

derived

PubMed Identifier

26120369

Citation

Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

Results Reference

derived

PubMed Identifier

26064192

Citation

Doody RS, Raman R, Sperling RA, Seimers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Sun X, Ernstrom K, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study. Peripheral and central effects of gamma-secretase inhibition by semagacestat in Alzheimer's disease. Alzheimers Res Ther. 2015 Jun 10;7(1):36. doi: 10.1186/s13195-015-0121-6. eCollection 2015.

Results Reference

derived

PubMed Identifier

23883379

Citation

Doody RS, Raman R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study Steering Committee; Siemers E, Sethuraman G, Mohs R; Semagacestat Study Group. A phase 3 trial of semagacestat for treatment of Alzheimer's disease. N Engl J Med. 2013 Jul 25;369(4):341-50. doi: 10.1056/NEJMoa1210951.

Results Reference

derived

Learn more about this trial

Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

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