NCT00762411

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 patients. The buildup 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 patients. In this trial, patients 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 patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study. Preliminary results from this study (LFBC) (and another similar study LFAN \[NCT00594568\]) 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. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,111

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2008

Typical duration for phase_3

Geographic Reach
18 countries

91 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

February 16, 2015

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

September 26, 2008

Results QC Date

November 6, 2013

Last Update Submit

January 28, 2015

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (4)

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

    The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and 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.

    Baseline (randomization), 76 weeks

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

    The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

    Baseline (randomization), 16 weeks following treatment cessation

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

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both 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.

    Baseline (randomization), 76 weeks

  • Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both 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.

    Baseline (randomization), 16 weeks following treatment cessation

Secondary Outcomes (25)

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

    Baseline (randomization), 76 weeks

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

    Baseline (randomization), 76 weeks

  • Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks

    Baseline (randomization), up to 76 weeks

  • Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks

    Baseline (randomization), 76 weeks

  • Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks

    Baseline (randomization), 76 weeks

  • +20 more secondary outcomes

Study Arms (2)

LY450139

EXPERIMENTAL

Participants received 60 milligrams (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.

Drug: LY450139

Placebo

PLACEBO COMPARATOR

Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.

Drug: Placebo

Interventions

LY450139DRUG

Administered orally once daily.

Also known as: Semagacestat
LY450139
PlaceboDRUG

Administered orally once daily.

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination score of 16 through 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 a least 12 consecutive months or have had both ovaries removed.

You may not qualify if:

  • Is not capable of swallowing whole oral medication
  • Has serious or unstable illnesses
  • Does not have a reliable caregiver
  • Chronic alcohol and/or drug abuse within the past 5 years
  • Has ever had a active vaccination for AD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (91)

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Phoenix, Arizona, 85004, United States

Location

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Costa Mesa, California, 92626, United States

Location

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La Jolla, California, 92037, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90036, United States

Location

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Oxnard, California, 93030, United States

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San Francisco, California, 94109, United States

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Boca Raton, Florida, 33431, United States

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Hallandale, Florida, 33009, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33137, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33609, United States

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New Orleans, Louisiana, 70131, United States

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Shreveport, Louisiana, 71104, United States

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Hattiesburg, Mississippi, 39401, United States

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Omaha, Nebraska, 68105, United States

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Albany, New York, 12205, United States

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Manhasset, New York, 11030, United States

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Durham, North Carolina, 27710, United States

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Oklahoma City, Oklahoma, 73103, United States

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Philadelphia, Pennsylvania, 19131, United States

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Rio de Janeiro, 21020-130, Brazil

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Salvador, 40301500, Brazil

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São Paulo, 040024-002, Brazil

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Sofia, 1527, Bulgaria

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Winnipeg, Manitoba, R3N 0K6, Canada

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Saint John, New Brunswick, E2L 3L6, Canada

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London, Ontario, N6C 5J1, Canada

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Ottawa, Ontario, K1N 5C8, Canada

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Peterborough, Ontario, K9H2P4, Canada

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Toronto, Ontario, M3B2S7, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Verdun, Quebec, H4H 1R3, Canada

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Beijing, 100853, China

Location

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Shanghai, 200025, China

Location

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Xi'an, 710038, China

Location

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Montpellier, 34295, France

Location

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Paris, 75651, France

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Poitiers, 86021, France

Location

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Strasbourg, 67091, France

Location

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Berlin, 10629, Germany

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Frankfurt, 60528, Germany

Location

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Hamburg, 22083, Germany

Location

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Heidelberg, 69115, Germany

Location

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Mannheim, 68165, Germany

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Budapest, H-1083, Hungary

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Esztergom, 2500, Hungary

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Boggiovara, 41100, Italy

Location

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Cassino, 03043, Italy

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Milan, 20122, Italy

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Parma, 43100, Italy

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Akita, 010-0874, Japan

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Fukuoka, 814-0180, Japan

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Hyōgo, 655-0037, Japan

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Ibaraki, 305-8576, Japan

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Kanagawa, 251-0038, Japan

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Kumamoto, 861-8002, Japan

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Kyoto, 606-0851, Japan

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Nagasaki, 852-8108, Japan

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Numakunai, 020-8505, Japan

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Osaka, 599-8263, Japan

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Saitama, 344-0036, Japan

Location

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Tokyo, 113-8655, Japan

Location

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Aguascalientes, 20217, Mexico

Location

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Monterrey, 64710, Mexico

Location

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Saltillo, 25000, Mexico

Location

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Bucharest, 011241, Romania

Location

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Timișoara, 300736, Romania

Location

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Kazan', 420101, Russia

Location

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Saint Petersburg, 190021, Russia

Location

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Saratov, 410028, Russia

Location

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Yekaterinburg, 620030, Russia

Location

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Belgrade, 11000, Serbia

Location

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Kragujevac, 34000, Serbia

Location

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Seoul, 139-707, South Korea

Location

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Suwon, 443-721, South Korea

Location

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Changhua, 500, Taiwan

Location

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Tainan, 70403, Taiwan

Location

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Taipei, 111, Taiwan

Location

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Taoyuan District, 333, Taiwan

Location

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Eskişehir, 26480, Turkey (Türkiye)

Location

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Istanbul, 34452, Turkey (Türkiye)

Location

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Izmir, 35340, Turkey (Türkiye)

Location

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Samsun, Turkey (Türkiye)

Location

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Dnipropetrovsk, 49616, Ukraine

Location

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Donetsk, 83037, Ukraine

Location

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Kherson, 73488, Ukraine

Location

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Kyiv, 04080, Ukraine

Location

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Odesa, 65006, Ukraine

Location

Related Publications (2)

  • 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.

    PMID: 26402769DERIVED

  • 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.

    PMID: 26120369DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

N2-((2S)-2-(3,5-difluorophenyl)-2-hydroxyethanoyl)-N1-((7S)-5-methyl-6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-L-alaninamide

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

All dosing for 4-week post-study drug cessation timeframe outcome measures stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening for LY450139 participants. No assessments made during 32-week follow up.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 16, 2015

Results First Posted

September 25, 2014

Record last verified: 2015-01

Locations

JP(12)BU(1)UA(5)HU(2)RU(4)TW(4)FR(4)RO(2)KR(2)US(22)CN(3)IT(4)TU(4)CA(9)DE(5)ME(3)SE(2)BR(3)