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Clinical Trials List

Protocol NumberH6L-MC-LFBC
NCT Number(ClinicalTrials.gov Identfier)NCT00762411

2008-01-01 - 2012-07-31

Phase III

Terminated5

ICD-10G30.0

Alzheimer's disease with early onset

ICD-10G30.1

Alzheimer's disease with late onset

ICD-10G30.8

Other Alzheimer's disease

ICD-10G30.9

Alzheimer's disease, unspecified

ICD-9331.0

Alzheimer's disease

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Jong-Ling Fuh Division of Neurology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chin-Chang Huang Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 巫錫霖 Division of Neurology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jung-Lung Hsu Division of Neurology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Chyi Pai Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Alzheimer's Disease

Objectives

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.

Test Drug

LY450139

Active Ingredient

LY450139

Dosage Form

tablet

Dosage

60 mg, 100 mg, 140 mg

Endpoints

1.Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks [ Time Frame: Baseline (randomization), 76 weeks ]
2.Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug [ Time Frame: Baseline (randomization), 16 weeks following treatment cessation ]
3.Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks [ Time Frame: Baseline (randomization), 76 weeks ]
4.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 [ Time Frame: Baseline (randomization), 16 weeks following treatment cessation ]

Inclution Criteria

1.Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination (MMSE) score of 16-26 at Visit 1
2.Modified Hachinski Ischemia Scale score of less than or equal to 4
3.Geriatric Depression Scale score of less than or equal to 6
A4. magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
5.If female, must be without menstruation for at least 12 consecutive months or have had both ovaries removed

Exclusion Criteria

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

The Estimated Number of Participants

  • Taiwan

    90 participants

  • Global

    1600 participants

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