Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ELND005 in Patients With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00568776
Recruitment Status : Completed
First Posted : December 6, 2007
Results First Posted : March 29, 2012
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited

Tracking Information
First Submitted Date  ICMJE December 4, 2007
First Posted Date  ICMJE December 6, 2007
Results First Submitted Date  ICMJE September 27, 2011
Results First Posted Date  ICMJE March 29, 2012
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
  • Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ]
    The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
  • Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS) [ Time Frame: Baseline and 78 weeks ]
    The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
  • Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ]
    The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
  • Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS) [ Time Frame: Baseline and 78 weeks ]
    The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
Safety and Tolerability; Cognitive and Functional Measures [ Time Frame: 18 months ]
Change History Complete list of historical versions of study NCT00568776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
  • Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ]
    The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.
  • Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ]
    The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.
  • Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ]
    The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease
Brief Summary The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD).
Detailed Description

ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD patients.

This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Placebo Control
    ELND005 matched placebo capsules for oral administration, bid for 78 weeks
    Other Name: scyllo-inositol
  • Drug: ELND005
    ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
  • Drug: ELND005
    ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
    Other Name: scyllo-inositol
  • Drug: ELND005
    ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
    Other Name: scyllo-inositol
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: Placebo Control
  • Active Comparator: 2
    Intervention: Drug: ELND005
  • Active Comparator: 3
    Intervention: Drug: ELND005
  • Active Comparator: 4
    Intervention: Drug: ELND005
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2012)
353
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2007)
340
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age 50 to 85 years, inclusive
  • Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Fluency in English, French, or Spanish
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver is able to attend all study visits

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant medical illness
  • History of stroke or seizure
  • History of a heart attack within the last 2 years
  • Prior treatment with certain experimental medicines
  • Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having MRI scan
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00568776
Other Study ID Numbers  ICMJE ELND005-AD201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Transition Therapeutics Ireland Limited
Study Sponsor  ICMJE Transition Therapeutics Ireland Limited
Collaborators  ICMJE Transition Therapeutics
Investigators  ICMJE Not Provided
PRS Account Transition Therapeutics Ireland Limited
Verification Date April 2016

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