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Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo (IDENTITY-2)
This study is currently recruiting participants.
Verified by Eli Lilly and Company, January 2010
First Received: September 26, 2008   Last Updated: January 15, 2010   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00762411
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: LY450139
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1100
Study Start Date: September 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
LY450139 60mg by mouth once a day gradually escalated to 140 mg for the duration of the study.
Drug: LY450139
60mg orally once a day gradually escalated to 140mg orally once a day for the duration of the study
2: Placebo Comparator
Placebo by mouth once a day for a blinded period of the study.
Drug: Placebo
Once a day for a blinded period of time

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762411

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 91 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company ( Chief Medical Officer )
Study ID Numbers: 11271, H6L-MC-LFBC
Study First Received: September 26, 2008
Last Updated: January 15, 2010
ClinicalTrials.gov Identifier: NCT00762411     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Alzheimer's Disease

Additional relevant MeSH terms:
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Brain Diseases
Mental Disorders
Tauopathies
Dementia
Alzheimer Disease

ClinicalTrials.gov processed this record on February 08, 2010