NCT01035138

Brief Summary

The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF). Preliminary results from LFAN and LFBC 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 LFBF 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. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
14 countries

71 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

December 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
1.3 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

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

December 17, 2009

Results QC Date

November 6, 2013

Last Update Submit

September 22, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

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

    The cognitive subscale of the 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.

    Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

  • Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 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. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.

    Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

Secondary Outcomes (15)

  • Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12

    Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)

  • Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12

    Baseline (LFAN Randomization), 12 weeks (LFBF)

  • Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12

    Baseline (LFAN Randomization), 12 weeks (LFBF)

  • Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12

    Baseline (LFAN Randomization), 12 weeks (LFBF)

  • Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12

    Baseline (LFAN Randomization), 12 weeks (LFBF)

  • +10 more secondary outcomes

Study Arms (1)

Drug: semagacestat

EXPERIMENTAL
Drug: semagacestat

Interventions

semagacestatDRUG

140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability

Also known as: LY450139
Drug: semagacestat

Eligibility Criteria

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

You may qualify if:

  • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
  • Completed semagacestat study LFAN or study LFBC through 88 weeks
  • Must continue to have a reliable caregiver
  • Capable of swallowing whole oral medication
  • Agrees not to participate in other investigational compounds for the duration of study

You may not qualify if:

  • Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (71)

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Phoenix, Arizona, 85004, United States

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Sun City, Arizona, 85351, United States

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Tucson, Arizona, 85741, United States

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Costa Mesa, California, 92626, United States

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Fresno, California, 93720, United States

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Laguna Hills, California, 92653, United States

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Lomita, California, 90717, United States

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Orange, California, 92868, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94109, 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, 34601, United States

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Deerfield Beach, Florida, 33064, 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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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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St. Petersburg, Florida, 33716, United States

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Tampa Bay, Florida, 33613, United States

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Indianapolis, Indiana, 46202, United States

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Lexington, Kentucky, 40503, 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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Hyannis, Massachusetts, 02601, United States

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St Louis, Missouri, 63108, 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, 27103, 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

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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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Bennington, Vermont, 05201, United States

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Kogarah, New South Wales, 2217, Australia

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Geelong, Victoria, 3220, Australia

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Heidelberg West, Victoria, 3081, Australia

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Kelowna, British Columbia, V1Y3G8, Canada

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Penticton, British Columbia, V2A5C8, Canada

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Sherbrooke, Quebec, J1H1Z1, Canada

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Antofagasta, Chile

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Santiago, Chile

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Valdivia, Chile

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Kuopio, 70210, Finland

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Oulu, 90229, Finland

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Toulouse, TSA 60033, France

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Hanover, 30559, Germany

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München, 81675, Germany

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Regensburg, D-93053, Germany

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Siegen, 57072, Germany

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Ashkelon, 78306, Israel

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Petah Tikva, 49100, Israel

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Tel Litwinsky, 52661, Israel

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Milan, 20132, Italy

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Fukui, 910-3113, Japan

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Fukuoka, 770-8076, Japan

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Kochi, 780-0842, Japan

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Tokushima, 770-0852, Japan

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Lublin, 20-950, Poland

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Poznan, 61- 485, Poland

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Bellville, 7530, South Africa

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Barcelona, 08003, Spain

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Plasencia, 10600, Spain

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Stockholm, 14186, Sweden

Location

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

Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

December 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 25, 2014

Results First Posted

September 25, 2014

Record last verified: 2014-09

Locations

CL(3)IL(3)AU(3)US(41)DE(4)JP(4)PL(2)ZA(1)IT(1)SE(1)CA(3)FI(2)ES(2)FR(1)