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ELND005 in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00568776
First received: December 4, 2007
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Alzheimer Disease
Drug: Placebo Control
Drug: ELND005
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 353
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo Control
ELND005 matched placebo capsules for oral administration, bid for 78 weeks
Other Name: scyllo-inositol
Active Comparator: 2 Drug: ELND005
ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
Other Name: scyllo-inositol
Active Comparator: 3 Drug: ELND005
ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
Other Name: scyllo-inositol
Active Comparator: 4 Drug: ELND005
ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568776

  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Sun Health Research Institute
Sun City, Arizona, United States, 85351
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, United States, 85724
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
UCLA Alzheimer's Disease Center, Dept. of Neurology
Los Angeles, California, United States, 90095
UC Irvine Medical Center
Orange, California, United States, 92868
UCSF Medical Center, Dept. of Neurology
San Francisco, California, United States, 94143
United States, Connecticut
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center, Dept. of Neurology
Washington, District of Columbia, United States, 20057
United States, Florida
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445
Sunrise Clinical Research, Inc
Hollywood, Florida, United States, 33021
Avision Research Associates, LLC
Miami, Florida, United States, 33173
Miami Jewish Home and Hospital For The Aged
Miami, Florida, United States, 33137
Compass Research, LLC
Orlando, Florida, United States, 32806
Roskamp Institute
Sarasota, Florida, United States, 34243
Neurology Clinical Research, Inc.
Sunrise, Florida, United States, 33351
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, United States, 33617
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University, Dept. of Neurology
Atlanta, Georgia, United States, 30329
Dekalb Neurology Associates, LLC
Decatur, Georgia, United States, 30033
United States, Indiana
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States, 66160
United States, Kentucky
Innovative Clinical Concepts
Paducah, Kentucky, United States, 42003
United States, Massachusetts
Brigham and Women's Hospital, Dept. of Neurology
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan, Taubman Health Care Center, Dept. of Neurology
Ann Arbor, Michigan, United States, 48109
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
The Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Global Medical Institutes
Princeton, New Jersey, United States, 08540
United States, New Mexico
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurological Associates of Albany, PC
Albany, New York, United States, 12208
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Sergievsky Center
New York, New York, United States, 10032
AD-CARE, Monroe Community Hospital
Rochester, New York, United States, 14620
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oregon
Medford Neurological and Spine Clinic
Medford, Oregon, United States, 97504
Summit Research Newtwork, Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Abington Neurological Associates, Inc.
Abington, Pennsylvania, United States, 19001
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
University of Pittsburgh Alzheimer Disease Research Clinic
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Butler Hospital, Memory and Aging Center
Providence, Rhode Island, United States, 02906
United States, South Carolina
Alliance for Neuro Research, LLC dba Absher Neurology, PA
Greenville, South Carolina, United States, 29615
United States, Texas
Radiant Research San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah, Dept. of Neurology
Salt Lake City, Utah, United States, 84108
United States, Vermont
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington, Vermont, United States, 05201
University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Canada, Alberta
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T5G 0B7
Canada, British Columbia
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
London, Ontario, Canada, N6A 4V2
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Sisters of Charity of Ottawa Health Service
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H 2P4
Whitby Mental Health Memory Clinic
Toronto, Ontario, Canada, M5T 2S8
Gerontion Research, Inc.
Toronto, Ontario, Canada, M6M 3Z5
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Neuro-Rive-Sud Memory Clinic
Greenfield Park, Quebec, Canada, J4V 2J2
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Elan Pharmaceuticals
Transition Therapeutics
  More Information

No publications provided

Responsible Party: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00568776     History of Changes
Other Study ID Numbers: ELND005-AD201
Study First Received: December 4, 2007
Results First Received: September 27, 2011
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Inositol
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014