ELND005 in Patients With Mild to Moderate Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568776
• Other study ID #: ELND005-AD201
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: May 2010

Study information

• Verified date: October 2019
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Placebo Control
ELND005 matched placebo capsules for oral administration, bid for 78 weeks
• ELND005
ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
• ELND005
ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
• ELND005
ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks

Locations

Country	Name	City	State
Canada	Glenrose Rehabilitation Hospital	Edmonton	Alberta
Canada	Neuro-Rive-Sud Memory Clinic	Greenfield Park	Quebec
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	Parkwood Hospital	London	Ontario
Canada	Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology	London	Ontario
Canada	Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)	Montreal	Quebec
Canada	Sisters of Charity of Ottawa Health Service	Ottawa	Ontario
Canada	Kawartha Regional Memory Clinic	Peterborough	Ontario
Canada	Gerontion Research, Inc.	Toronto	Ontario
Canada	Toronto Memory Program	Toronto	Ontario
Canada	Whitby Mental Health Memory Clinic	Toronto	Ontario
Canada	University of British Columbia Hospital, Division of Neurology	Vancouver	British Columbia
United States	Abington Neurological Associates, Inc.	Abington	Pennsylvania
United States	Neurological Associates of Albany, PC	Albany	New York
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	University of Michigan, Taubman Health Care Center, Dept. of Neurology	Ann Arbor	Michigan
United States	Emory University, Dept. of Neurology	Atlanta	Georgia
United States	Clinical Neuroscience Research Associates, Inc-The Memory Clinic	Bennington	Vermont
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Brigham and Women's Hospital, Dept. of Neurology	Boston	Massachusetts
United States	University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology	Burlington	Vermont
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Dekalb Neurology Associates, LLC	Decatur	Georgia
United States	Brain Matters Research, Inc.	Delray Beach	Florida
United States	The Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Margolin Brain Institute	Fresno	California
United States	Collaborative NeuroScience Network, Inc.	Garden Grove	California
United States	Alliance for Neuro Research, LLC dba Absher Neurology, PA	Greenville	South Carolina
United States	Sunrise Clinical Research, Inc	Hollywood	Florida
United States	Department of Neurology - Indiana University Medical Center	Indianapolis	Indiana
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	University of Kansas Medical Center, Department of Neurology	Kansas City	Kansas
United States	University of Nevada School of Medicine	Las Vegas	Nevada
United States	UCLA Alzheimer's Disease Center, Dept. of Neurology	Los Angeles	California
United States	Medford Neurological and Spine Clinic	Medford	Oregon
United States	Avision Research Associates, LLC	Miami	Florida
United States	Miami Jewish Home and Hospital For The Aged	Miami	Florida
United States	Yale University School of Medicine, Alzheimer's Disease Research Unit	New Haven	Connecticut
United States	Columbia University Sergievsky Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	UC Irvine Medical Center	Orange	California
United States	Compass Research, LLC	Orlando	Florida
United States	Innovative Clinical Concepts	Paducah	Kentucky
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	University of Pittsburgh Alzheimer Disease Research Clinic	Pittsburgh	Pennsylvania
United States	Summit Research Newtwork, Inc.	Portland	Oregon
United States	Global Medical Institutes	Princeton	New Jersey
United States	Butler Hospital, Memory and Aging Center	Providence	Rhode Island
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	AD-CARE, Monroe Community Hospital	Rochester	New York
United States	University of Utah, Dept. of Neurology	Salt Lake City	Utah
United States	Radiant Research San Antonio	San Antonio	Texas
United States	UCSF Medical Center, Dept. of Neurology	San Francisco	California
United States	Roskamp Institute	Sarasota	Florida
United States	Sun Health Research Institute	Sun City	Arizona
United States	Neurology Clinical Research, Inc.	Sunrise	Florida
United States	University of South Florida Suncoast Alzheimer's and Gerontology Center	Tampa	Florida
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
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	Premiere Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)	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.	Baseline and 78 weeks
Primary	Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)	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.	Baseline and 78 weeks
Primary	Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)	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.	Baseline and 78 weeks
Primary	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)	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.	Baseline and 78 weeks
Secondary	Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)	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.	Baseline and 78 weeks
Secondary	Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)	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.	Baseline and 78 weeks
Secondary	Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)	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.	Baseline and 78 weeks