Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo (IDENTITY-2)

Tracking Information

Start Date  ICMJESeptember 2008
Estimated Primary Completion DateMarch 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog). Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00762411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 26, 2008)
  • The Clinical Dementia Rating Scale (CDR) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Resource Utilisation in Dementia - Lite Questionnaire (RUD-Lite) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • EuroQol-5D Proxy (EQ-5D Proxy) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Quality of Life in Alzheimer's Disease (Qol-AD) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Mini-mental State Examination (MMSE) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • A chemical marker of AD in the blood which may be lowered by LY450139. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Energy usage (metabolism) seen on a brain scan called FDG-PET [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • Brain size (volume) seen with AD on a brain scan called vMRI [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • Amount of brain amyloid plaque using a brain scan called AV-45-PET [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • A chemical marker (tau) known to be elevated in the spinal fluid in AD [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • To measure levels of LY450139 and their effect on safety, chemical markers and effectiveness. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEEffects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo
Official Title  ICMJEEffect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo
Brief Summary

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no known cure. AD causes brain cells to die. AD is thought to be caused by an excess of Beta amyloid (Aβ), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme γ-secretase inhibits the production of (Aβ) as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both (Aβ)and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient's participation will last approximately 2 years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAlzheimer's Disease
Intervention  ICMJE
  • Drug: LY450139
    60mg orally once a day gradually escalated to 140mg orally once a day for the duration of the study
    Other Name: semagacestat
  • Drug: Placebo
    Once a day for a blinded period of time
Study Arms / Comparison Groups
  • 1: Experimental
    LY450139 60mg by mouth once a day gradually escalated to 140 mg for the duration of the study.
    Intervention: Drug: LY450139
  • 2: Placebo Comparator
    Placebo by mouth once a day for a blinded period of the study.
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1100
Estimated Completion DateMarch 2012
Estimated Primary Completion DateMarch 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets criteria for mild to moderate 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.

Exclusion Criteria:

  • 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
Ages55 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Brazil,   Bulgaria,   Canada,   China,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Romania,   Russian Federation,   Serbia,   Taiwan,   Turkey,   Ukraine

Administrative Information

Responsible PartyChief Medical Officer, Eli Lilly and Company
Study ID Numbers  ICMJE11271, H6L-MC-LFBC
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
Investigators  ICMJE
Study Director: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
Information Provided ByEli Lilly and Company