Clinical trial NCT00568776: ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 353
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
timeFrame: Baseline and 78 weeks
measure: Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
timeFrame: Baseline and 78 weeks
measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
timeFrame: Baseline and 78 weeks
measure: 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)
timeFrame: Baseline and 78 weeks
Secondary outcomes:
measure: Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)
timeFrame: Baseline and 78 weeks
measure: Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)
timeFrame: Baseline and 78 weeks
measure: Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)
timeFrame: Baseline and 78 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona, Health Sciences Center, Dept. of Neurology
state: Arizona
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Alzheimer's Disease Center, Dept. of Neurology
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center, Dept. of Neurology
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine, Alzheimer's Disease Research Unit
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center, Dept. of Neurology
state: District of Columbia
city: Delray Beach
country: United States
facility: Brain Matters Research, Inc.
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: Miami Jewish Home and Hospital For The Aged
state: Florida
city: Miami
country: United States
facility: Avision Research Associates, LLC
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida Suncoast Alzheimer's and Gerontology Center
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University, Dept. of Neurology
state: Georgia
city: Decatur
country: United States
facility: Dekalb Neurology Associates, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Department of Neurology - Indiana University Medical Center
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Department of Neurology
state: Kansas
city: Paducah
country: United States
facility: Innovative Clinical Concepts
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital, Dept. of Neurology
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Taubman Health Care Center, Dept. of Neurology
state: Michigan
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Eatontown
country: United States
facility: The Memory Enhancement Center of America, Inc.
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Sergievsky Center
state: New York
city: Rochester
country: United States
facility: AD-CARE, Monroe Community Hospital
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Medford
country: United States
facility: Medford Neurological and Spine Clinic
state: Oregon
city: Portland
country: United States
facility: Summit Research Newtwork, Inc.
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates, Inc.
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Alzheimer Disease Research Clinic
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital, Memory and Aging Center
state: Rhode Island
city: Greenville
country: United States
facility: Alliance for Neuro Research, LLC dba Absher Neurology, PA
state: South Carolina
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Dept. of Neurology
state: Utah
city: Bennington
country: United States
facility: Clinical Neuroscience Research Associates, Inc-The Memory Clinic
state: Vermont
city: Burlington
country: United States
facility: University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia Hospital, Division of Neurology
state: British Columbia
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: London
country: Canada
facility: Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Sisters of Charity of Ottawa Health Service
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Whitby Mental Health Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Gerontion Research, Inc.
state: Ontario
city: Greenfield Park
country: Canada
facility: Neuro-Rive-Sud Memory Clinic
state: Quebec
city: Montreal
country: Canada
facility: Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
state: Quebec
Study officials:
References: