Trial record 1 of 1 for:    NCT00762411
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00762411
First received: September 26, 2008
Last updated: August 22, 2011
Last verified: April 2011

September 26, 2008
August 22, 2011
September 2008
April 2011   (final data collection date for primary outcome measure)
  • Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog11) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog11) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks, 8weeks, 16 weeks, 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks, 8weeks, 16 weeks, 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00762411 on ClinicalTrials.gov Archive Site
  • Change in Clinical Dementia Rating (Sum of Boxes) (CDR-SB) during Treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Neuropsychiatric Inventory (NPI) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Resource Utilization in Dementia - Lite Questionnaire (RUD-Lite) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in EuroQol 5-Dimensional Health-related Quality of Life scale (EQ-5D) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Quality of Life in Alzheimer's Disease (Qol-AD) during treatment [ Time Frame: Baseline (randomization), 28 weeks, 52 weeks and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Mini-mental State Examination (MMSE) during treatment [ Time Frame: Baseline (randomization), 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in amyloid beta plasma concentration [ Time Frame: Baseline (randomization), 6 weeks, 12 weeks, 52 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in positron emission tomography (PET) using fluorine- 18 fluorodeoxyglucose (FDG-PET) [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in amyloid imaging positron emission tomography (AV-45) [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change in tau concentration in spinal fluid [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Clearance and volume of distribution of LY450139 will be reported [ Time Frame: 6 weeks, 12 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in Clinical Dementia Rating (Sum of Boxes) (CDR-SB) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Neuropsychiatric Inventory (NPI) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Resource Utilization in Dementia - Lite Questionnaire (RUD-Lite) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in EuroQol 5-Dimensional Health-related Quality of Life scale (EQ-5D) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Quality of Life in Alzheimer's Disease (Qol-AD) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Mini-mental State Examination (MMSE) after cessation of study drug [ Time Frame: Baseline (randomization); 4 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog12) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog14) during treatment [ Time Frame: Baseline (randomization), 12 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, and 76 weeks ] [ Designated as safety issue: No ]
  • Change in phospho-tau concentration in spinal fluid [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change in amyloid beta 42 concentration in spinal fluid [ Time Frame: Baseline (randomization) and 76 weeks ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog12) after cessation of study drug [ Time Frame: Baseline (randomization), 4 weeks, 8 weeks, 16 weeks, and 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • Change in Alzheimer's Disease Assessment Scale (ADAS-Cog14) after cessation of study drug [ Time Frame: Baseline (randomization), 4 weeks, 8 weeks, 16 weeks, and 32 weeks (following treatment cessation) ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo
Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo

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, 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 lowers the production of beta amyloid. Semagacestat (LY450139) is a functional gamma-secretase inhibitor and was shown to lower beta 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 beta amyloid and amyloid plaques for some patients. 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 patients. In this trial, patients 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 patients could eventually receive active drug. Each patient's participation could last approximately two years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from LFBC (and another similar study LFAN) 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. LFBC, LFAN and open label 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: LY450139
    60mg administered orally once daily, gradually escalated to 140 mg for the duration of the study
    Other Name: semagacestat
  • Drug: Placebo
    Administered orally once daily for the duration of the study
  • Experimental: LY450139
    Intervention: Drug: LY450139
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Bulgaria,   Canada,   China,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Romania,   Russian Federation,   Serbia,   Taiwan,   Turkey,   Ukraine
 
NCT00762411
11271, H6L-MC-LFBC
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP