ELND005 in Patients With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT00568776
- Lead Sponsor
- OPKO Health, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Control - 2 ELND005 - 3 ELND005 - 4 ELND005 -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) 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) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) 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) 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) 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.
Trial Locations
- Locations (62)
Brain Matters Research, Inc.
🇺🇸Delray Beach, Florida, United States
Sunrise Clinical Research, Inc
🇺🇸Hollywood, Florida, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
UCLA Alzheimer's Disease Center, Dept. of Neurology
🇺🇸Los Angeles, California, United States
Avision Research Associates, LLC
🇺🇸Miami, Florida, United States
University of British Columbia Hospital, Division of Neurology
🇨🇦Vancouver, British Columbia, Canada
Roskamp Institute
🇺🇸Sarasota, Florida, United States
Miami Jewish Home and Hospital For The Aged
🇺🇸Miami, Florida, United States
Collaborative NeuroScience Network, Inc.
🇺🇸Garden Grove, California, United States
Department of Neurology - Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Nevada School of Medicine
🇺🇸Las Vegas, Nevada, United States
Columbia University Sergievsky Center
🇺🇸New York, New York, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
University of Arizona, Health Sciences Center, Dept. of Neurology
🇺🇸Tucson, Arizona, United States
Georgetown University Medical Center, Dept. of Neurology
🇺🇸Washington, District of Columbia, United States
Innovative Clinical Concepts
🇺🇸Paducah, Kentucky, United States
Neurological Associates of Albany, PC
🇺🇸Albany, New York, United States
Medford Neurological and Spine Clinic
🇺🇸Medford, Oregon, United States
Global Medical Institutes
🇺🇸Princeton, New Jersey, United States
Whitby Mental Health Memory Clinic
🇨🇦Toronto, Ontario, Canada
Brigham and Women's Hospital, Dept. of Neurology
🇺🇸Boston, Massachusetts, United States
Glenrose Rehabilitation Hospital
🇨🇦Edmonton, Alberta, Canada
Dekalb Neurology Associates, LLC
🇺🇸Decatur, Georgia, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Alliance for Neuro Research, LLC dba Absher Neurology, PA
🇺🇸Greenville, South Carolina, United States
University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
🇺🇸Burlington, Vermont, United States
University of Pittsburgh Alzheimer Disease Research Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
Parkwood Hospital
🇨🇦London, Ontario, Canada
Sisters of Charity of Ottawa Health Service
🇨🇦Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
🇨🇦Peterborough, Ontario, Canada
Neurology & Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
🇨🇦Montreal, Quebec, Canada
University of Kansas Medical Center, Department of Neurology
🇺🇸Kansas City, Kansas, United States
UCSF Medical Center, Dept. of Neurology
🇺🇸San Francisco, California, United States
Radiant Research San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah, Dept. of Neurology
🇺🇸Salt Lake City, Utah, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Summit Research Newtwork, Inc.
🇺🇸Portland, Oregon, United States
Neuro-Rive-Sud Memory Clinic
🇨🇦Greenfield Park, Quebec, Canada
Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Emory University, Dept. of Neurology
🇺🇸Atlanta, Georgia, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
The Memory Enhancement Center of America, Inc.
🇺🇸Eatontown, New Jersey, United States
AD-CARE, Monroe Community Hospital
🇺🇸Rochester, New York, United States
Abington Neurological Associates, Inc.
🇺🇸Abington, Pennsylvania, United States
Butler Hospital, Memory and Aging Center
🇺🇸Providence, Rhode Island, United States
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
🇺🇸Bennington, Vermont, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
🇨🇦London, Ontario, Canada
Neurology Clinical Research, Inc.
🇺🇸Sunrise, Florida, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Gerontion Research, Inc.
🇨🇦Toronto, Ontario, Canada
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
🇺🇸New Haven, Connecticut, United States
University of South Florida Suncoast Alzheimer's and Gerontology Center
🇺🇸Tampa, Florida, United States
University of Michigan, Taubman Health Care Center, Dept. of Neurology
🇺🇸Ann Arbor, Michigan, United States