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A Study of Semagacestat for Alzheimer's Patients (Identity XT)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01035138
First received: December 17, 2009
Last updated: August 9, 2011
Last verified: July 2011
History of Changes
  Purpose

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 for feeder studies LFAN and LFBC. For all safety analyses, baseline for patients will be week 0 of 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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: semagacestat
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from cessation of study drug in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11) [ Time Frame: Baseline (last assessment before cessation of study drug), 4 weeks, 8 weeks, 16 weeks and 32 weeks ] [ Designated as safety issue: Yes ]
  • Change from cessation of study drug in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline (last assessment before cessation of study drug), 4 weeks, 8 weeks, 16 weeks and 32 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline of ABeta plasma levels [ Time Frame: Baseline (Randomization LFAN and LFBC), 3 months (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in amyloid imaging positron emission tomography (AV-45-PET) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11) [ Time Frame: Baseline (Randomization LFAN and LFBC), 3 months (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog12) [ Time Frame: Baseline (Randomization LFAN and LFBC), 3 months (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog14) [ Time Frame: Baseline (Randomization LFAN and LFBC), 3 months (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline (Randomization LFAN and LFBC), 3 months (LFBF) ] [ Designated as safety issue: No ]
  • Mean concentration of semagacestat [ Time Frame: 3 months (pre-dose, 2, 4, and 6 hours after dosing) (LFBF) ] [ Designated as safety issue: No ]
  • Change from cessation of study drug in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog12) [ Time Frame: Baseline (last assessment before cessation of study drug), 4 weeks, 8 weeks, 16 weeks and 32 weeks (LFBF) ] [ Designated as safety issue: Yes ]
  • Change from cessation of study drug in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog14) [ Time Frame: Baseline (last assessment before cessation of study drug), 4 weeks, 8 weeks, 16 weeks and 32 weeks (LFBF) ] [ Designated as safety issue: Yes ]
  • Change from baseline in Clinical Dementia Rating Scale (CDR-SB) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in EuroQol-5D (EQ-5D) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]
  • Change from baseline in Resource Utilization in Dementia - Lite Questionnaire (RUD-Lite) [ Time Frame: Baseline (Randomization LFAN and LFBC), 4 weeks after cessation of study drug (LFBF) ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: December 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: semagacestat Drug: semagacestat
140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
Other Names:
  • semagacestat
  • LY450139

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035138

  Show 71 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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01035138     History of Changes
Other Study ID Numbers: 5930, H6L-MC-LFBF
Study First Received: December 17, 2009
Last Updated: August 9, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Department of Health
Sweden: Medical Products Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013