NCT00594568

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.

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
1,537

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2008

Typical duration for phase_3

Geographic Reach
19 countries

148 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

First Submitted

Initial submission to the registry

January 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

January 11, 2008

Results QC Date

November 6, 2013

Last Update Submit

March 13, 2015

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline (randomization), 76 weeks

  • 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.

    Baseline (randomization), 16 weeks following treatment cessation

  • 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.

    Baseline (randomization), 76 weeks

  • 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

    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.

    Baseline (randomization), 16 weeks following treatment cessation

Secondary Outcomes (23)

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

    Baseline (randomization), 52 weeks

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

    Baseline (randomization), 76 weeks

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

    Baseline (randomization), up to 76 weeks

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

    Baseline (randomization), up to 76 weeks

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

    Baseline (randomization), up to 76 weeks

  • +18 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

100 mg LY450139

EXPERIMENTAL

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

Drug: LY450139

140 mg LY450139

EXPERIMENTAL

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.

Drug: LY450139

Interventions

LY450139DRUG

Administered orally once daily

Also known as: semagacestat
100 mg LY450139140 mg 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 (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

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 or drug abuse within the past 5 years
  • Has ever had active vaccination for AD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (148)

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Birmingham, Alabama, 35294, United States

Location

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Phoenix, Arizona, 85006, United States

Location

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Sun City, Arizona, 85351, United States

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Tucson, Arizona, 85741, United States

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Fresno, California, 93720, United States

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Lomita, California, 90717, United States

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Orange, California, 92868, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92103, United States

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Santa Monica, California, 90404, United States

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Hamden, Connecticut, 06518, United States

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New Haven, Connecticut, 06510, United States

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Washington D.C., District of Columbia, 20057, United States

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Brooksville, Florida, 34613, United States

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Fort Lauderdale, Florida, 33308, United States

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Fort Myers, Florida, 33912, United States

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Miami, Florida, 33140, United States

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Pompano Beach, Florida, 33064, United States

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St. Petersburg, Florida, 33716, United States

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Sunrise, Florida, 33351, United States

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Tampa, Florida, 33613, United States

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Tampa Bay, Florida, 33613, United States

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West Palm Beach, Florida, 33407, United States

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Chicago, Illinois, 60611, United States

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Indianapolis, Indiana, 46202, United States

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Lexington, Kentucky, 40503, United States

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Shreveport, Louisiana, 71101, United States

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Baltimore, Maryland, 21224, United States

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Boston, Massachusetts, 02118, United States

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Burlington, Massachusetts, 01805, United States

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West Yarmouth, Massachusetts, 02673, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63108, United States

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Albany, New York, 12208, United States

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New York, New York, 10032, United States

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Durham, North Carolina, 27705, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27157, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43623, United States

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Oklahoma City, Oklahoma, 73116, United States

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Eugene, Oregon, 97401, United States

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Jenkintown, Pennsylvania, 19046, United States

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Philadelphia, Pennsylvania, 19104, United States

Location

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Pittsburgh, Pennsylvania, 15213, United States

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East Providence, Rhode Island, 02914, United States

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North Charleston, South Carolina, 29406, United States

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Salt Lake City, Utah, 84108, United States

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Bennington, Vermont, 05201, United States

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Madison, Wisconsin, 53705, United States

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Buenos Aires, 1425, Argentina

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Córdoba, X5004AOA, Argentina

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Santa Fe, S3000FWO, Argentina

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Hornsby, New South Wales, 2077, Australia

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Kogarah, New South Wales, 2217, Australia

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Randwick, Sydney, New South Wales, 2013, Australia

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Adelaide, South Australia, 5000, Australia

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Geelong, Victoria, 3220, Australia

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Heidelberg West, Victoria, 3081, Australia

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Kew, Victoria, 3101, Australia

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Nedlands, Western Australia, 6009, Australia

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Aalst, 9300, Belgium

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Antwerp, 2020, Belgium

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Bruges, 8000, Belgium

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Leuven, 3000, Belgium

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Kelowna, British Columbia, V1Y3G8, Canada

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Penticton, British Columbia, V2A5C8, Canada

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Québec, Quebec, G1R 3X5, Canada

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Sherbrooke, Quebec, J1H1Z1, Canada

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Antofagasta, Chile

Location

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Concepción, Chile

Location

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Santiago, 6640870, Chile

Location

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Santiago, Chile

Location

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Valdivia, Chile

Location

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Viña del Mar, Chile

Location

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Copenhagen, 2100, Denmark

Location

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Roskilde, 4000, Denmark

Location

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Svendborg, 4000, Denmark

Location

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Kuopio, 70210, Finland

Location

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Mikkeli, 50100, Finland

Location

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Oulu, 90229, Finland

Location

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Nice, 06002, France

Location

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Rennes, 35000, France

Location

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Rouen, 76036, France

Location

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Toulouse, 31059, France

Location

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Tours, 37044, France

Location

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Dresden, 01307, Germany

Location

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Göttingen, 37075, Germany

Location

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Hanover, 30559, Germany

Location

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München, BY 80336, Germany

Location

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Regensburg, D-93053, Germany

Location

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Siegen, 57072, Germany

Location

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Chennai, 600003, India

Location

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Hyderabaad, 400082, India

Location

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Kolkata, 700054, India

Location

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Mangalore, 575002, India

Location

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Mumbai, 400050, India

Location

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Thiruvananthapuram, 695011, India

Location

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Tirupati, 517507, India

Location

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Varanasi, 221005, India

Location

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Ashkelon, 78306, Israel

Location

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Beersheba, 84170, Israel

Location

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Haifa, 31096, Israel

Location

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Jerusalem, 91240, Israel

Location

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Petah Tikva, 49100, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Tel Litwinsky, 52661, Israel

Location

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Milan, 20157, Italy

Location

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Pisa, 56126, Italy

Location

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Rome, 00153, Italy

Location

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Fukui, 910-3113, Japan

Location

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Fukuoka, 770-8076, Japan

Location

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Kagawa, 761-0793, Japan

Location

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Kochi, 780-0842, Japan

Location

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Osaka, 590-0018, Japan

Location

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Tokushima, 770-8076, Japan

Location

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Bialystok, 15402, Poland

Location

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Gdynia, 81-361, Poland

Location

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Lodz, 92-216, Poland

Location

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Lublin, 20-950, Poland

Location

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Poznan, 61-606, Poland

Location

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Warsaw, 02-507, Poland

Location

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Bellair, 4094, South Africa

Location

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Bellville, 7530, South Africa

Location

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Cape Town, 7925, South Africa

Location

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George, 6529, South Africa

Location

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Johannesburg, 1709, South Africa

Location

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Rosebank, 2132, South Africa

Location

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Somerset West, 7130, South Africa

Location

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Umhlanga, 4319, South Africa

Location

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Albacete, 2006, Spain

Location

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Barakaldo, 48903, Spain

Location

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Barcelona, 08014, Spain

Location

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Madrid, 28034, Spain

Location

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Plasencia, 10600, Spain

Location

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Malmo, 20502, Sweden

Location

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Mölndal, 43185, Sweden

Location

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Norrköping, 60172, Sweden

Location

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Stockholm, 14186, Sweden

Location

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Uddevalla, 45180, Sweden

Location

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Bath, Banes, BA1 3NG, United Kingdom

Location

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Southampton, Hants, SO30 3JB, United Kingdom

Location

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Liverpool, Merseyside, L9 7LJ, United Kingdom

Location

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Glasgow, Scotland, G20 0XA, United Kingdom

Location

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Swindon, Wilts, SN1 4JU, United Kingdom

Location

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Belfast, BT9 7BL, United Kingdom

Location

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Newcastle, NE4 6BE, United Kingdom

Location

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Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Publications (4)

  • 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

  • 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.

    PMID: 26064192DERIVED

  • 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.

    PMID: 23883379DERIVED

Related Links

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

Outcomes with 4-week after study drug cessation timeframe=All dosing stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening for LY450139 participants; followed for 32 weeks; not all assessments were made.

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

January 11, 2008

First Posted

January 15, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 17, 2015

Results First Posted

September 25, 2014

Record last verified: 2015-03

Locations

AU(8)JP(6)BE(4)DK(3)PL(6)ZA(8)CL(6)IT(3)AR(3)DE(6)US(50)IN(8)ES(5)GB(8)FR(5)CA(4)FI(3)SE(5)IL(7)